21 Lead Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Lead Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is seeking an accomplished Lead Pharmaceutical Quality Assurance Specialist to oversee and enhance their quality management systems, operating entirely remotely. This crucial role ensures that all pharmaceutical products and processes comply with stringent regulatory standards, internal policies, and customer requirements. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, conducting thorough audits, and leading investigations into deviations and non-conformities. The ideal candidate will possess a strong background in pharmaceutical sciences, quality control, or a related field, with extensive experience in GMP (Good Manufacturing Practices) and regulatory compliance. Responsibilities include managing quality documentation, coordinating quality review boards, and collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive quality initiatives. You will also be responsible for training and mentoring junior QA staff, fostering a culture of quality excellence throughout the organization. This position demands exceptional analytical and problem-solving skills, meticulous attention to detail, and outstanding communication and interpersonal abilities to effectively influence and collaborate in a remote setting. You will play a pivotal role in ensuring the safety, efficacy, and integrity of our pharmaceutical products, thereby safeguarding patient health and maintaining the company's reputation. Experience with pharmaceutical quality systems software and a thorough understanding of global regulatory requirements (FDA, EMA, etc.) are essential. This is an unparalleled opportunity for a dedicated QA professional to lead significant quality assurance efforts, drive continuous improvement, and contribute to the development of life-saving medicines in a challenging and rewarding remote role. If you are passionate about pharmaceutical quality and possess the leadership expertise to excel, we encourage you to apply.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is actively seeking a Lead Pharmaceutical Quality Assurance Specialist to ensure the highest standards of quality and compliance within our pharmaceutical operations. This is a fully remote opportunity, allowing you to contribute to vital quality assurance initiatives from the convenience of your home office. You will be responsible for developing, implementing, and maintaining robust quality management systems in accordance with global regulatory standards (e.g., GMP, ISO). Your key duties will include conducting internal audits, reviewing and approving quality-related documentation such as SOPs, batch records, and validation protocols, and managing deviation and CAPA (Corrective and Preventive Action) systems. You will also play a crucial role in supplier qualification and audits, ensuring that all raw materials and finished products meet stringent quality specifications. This position requires a deep understanding of pharmaceutical manufacturing processes, analytical testing, and regulatory requirements. You will lead and mentor junior QA team members, provide training on quality procedures, and collaborate closely with R&D, manufacturing, and regulatory affairs departments to ensure product integrity and patient safety. The ideal candidate will possess strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities. Effective communication and presentation skills are essential for reporting quality metrics and interacting with regulatory bodies. This role is pivotal in upholding our commitment to pharmaceutical excellence. The work will support and influence our operations and quality standards relevant to **Ongata Rongai, Kajiado, KE**, and other global sites.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 18 days ago
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Job Description
Our client is seeking a highly experienced and detail-oriented Lead Pharmaceutical Quality Assurance Specialist to ensure the highest standards of compliance and product integrity within their fully remote operations. This critical role involves developing, implementing, and maintaining robust quality management systems in accordance with global regulatory standards. The ideal candidate will possess deep expertise in pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. You will lead quality initiatives, conduct audits, and drive continuous improvement, all from a remote work setting. This is a remote-first position, offering a significant opportunity for impact from anywhere in Kenya.
Responsibilities:
Responsibilities:
- Develop, implement, and manage comprehensive Quality Assurance (QA) programs for pharmaceutical products and processes.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory guidelines (e.g., FDA, EMA).
- Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Develop and maintain the company's Quality Management System (QMS), including SOPs, work instructions, and quality agreements.
- Provide training to personnel on QA principles, GMP, and regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Manage the release of finished pharmaceutical products.
- Stay current with evolving regulatory landscapes and industry best practices.
- Lead quality improvement initiatives and contribute to the continuous enhancement of quality systems.
- Prepare for and host regulatory inspections.
- Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related scientific field.
- A minimum of 8 years of experience in Pharmaceutical Quality Assurance and Quality Control, with a strong focus on GMP compliance.
- In-depth knowledge of pharmaceutical manufacturing processes, analytical testing, and stability studies.
- Proven experience in conducting audits and managing CAPA systems.
- Familiarity with global regulatory requirements and submission processes.
- Excellent understanding of quality risk management principles.
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Demonstrated leadership capabilities and the ability to manage projects and teams remotely.
- Proficiency in using quality management software and standard office applications.
- Relevant professional certifications (e.g., ASQ CQA) are a plus.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 18 days ago
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Job Description
Our client, a leading pharmaceutical innovator, is seeking a highly skilled and motivated Lead Pharmaceutical Quality Assurance Specialist to join their dynamic team. This role offers a hybrid work arrangement, combining the benefits of remote flexibility with essential on-site collaboration. You will be responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. This involves developing, implementing, and maintaining comprehensive quality management systems in accordance with regulatory requirements and company policies. Your duties will include conducting internal audits, reviewing batch records, investigating deviations and out-of-specification results, and implementing corrective and preventive actions (CAPAs). You will also be involved in the validation of manufacturing processes and equipment, as well as authoring and revising quality-related documents, such as SOPs and validation protocols. The ideal candidate will possess a deep understanding of GMP (Good Manufacturing Practices), regulatory guidelines (e.g., FDA, EMA), and quality control principles within the pharmaceutical industry. Strong analytical and problem-solving skills, meticulous attention to detail, and excellent written and verbal communication abilities are essential. You will collaborate closely with various departments, including manufacturing, research and development, and regulatory affairs, to foster a culture of quality throughout the organization. This position requires a proactive approach to identifying potential quality issues and implementing effective solutions to mitigate risks. The ability to train and mentor junior team members will also be a key aspect of this role.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) for pharmaceutical products.
- Conduct thorough internal audits to ensure compliance with GMP and other regulatory standards.
- Review and approve batch records, validation reports, and other critical quality documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing effective CAPAs.
- Oversee and participate in the validation of manufacturing processes, equipment, and analytical methods.
- Author, review, and approve Standard Operating Procedures (SOPs), work instructions, and other quality-related documents.
- Collaborate with manufacturing, R&D, and regulatory affairs teams to ensure quality compliance.
- Stay updated on current Good Manufacturing Practices (cGMP) and relevant global regulatory requirements.
- Provide training and guidance to junior quality assurance personnel.
- Support external regulatory inspections and customer audits.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5-8 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Proven experience with QMS, audits, investigations, and CAPA management.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong technical writing and communication skills.
- Experience with pharmaceutical manufacturing processes and analytical techniques.
- Ability to work effectively both independently and as part of a cross-functional team.
- Experience in a hybrid work environment is beneficial.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 18 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is looking for a Lead Pharmaceutical Quality Assurance Specialist to join their fully remote team. In this critical role, you will be responsible for upholding the highest standards of quality and compliance throughout the pharmaceutical product lifecycle. Your expertise will be crucial in ensuring that all products meet stringent regulatory requirements and internal quality standards before release to the market. Key responsibilities include developing, implementing, and maintaining quality management systems, conducting internal audits and inspections, reviewing and approving batch records, and investigating deviations and out-of-specification results. You will also play a vital role in change control management, risk assessments, and validation activities. This position requires a deep understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant pharmaceutical regulations (e.g., FDA, EMA). You will work collaboratively with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to identify and address quality issues proactively. The ability to lead and mentor junior QA personnel, as well as to drive continuous improvement initiatives, is essential. This role is designed for a detail-oriented professional with exceptional problem-solving skills and a commitment to ensuring patient safety and product efficacy. As this is a remote-first position, strong self-discipline, excellent communication, and virtual collaboration skills are required. The job location for this role, though remote, is associated with projects and oversight impacting the **Ongata Rongai, Kajiado** region.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is looking for a highly skilled and experienced Lead Pharmaceutical Quality Assurance Specialist to join their dynamic team. This is a fully remote position, offering a fantastic opportunity to contribute to high-stakes pharmaceutical quality control from the comfort of your home office. You will be responsible for developing, implementing, and maintaining robust quality systems that ensure compliance with all relevant regulatory requirements (e.g., GMP, FDA, EMA). Your duties will include overseeing quality audits, managing deviations and CAPA systems, reviewing and approving batch records, and ensuring the integrity of pharmaceutical products throughout their lifecycle. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality management principles. Strong leadership and communication skills are essential, as you will be guiding a team of QA professionals and liaising with various departments, including R&D, manufacturing, and regulatory affairs. Experience with validation protocols and stability studies is highly desirable. This role demands exceptional attention to detail, strong analytical capabilities, and the ability to make critical quality decisions. As a remote specialist, you will be expected to utilize digital tools effectively for documentation, reporting, and collaborative decision-making. You will play a pivotal role in upholding our client's commitment to product safety, efficacy, and quality. We are seeking an individual with a proactive approach to quality assurance, who can identify potential risks and implement mitigation strategies. This position offers a challenging and rewarding career path, contributing to the delivery of life-saving medications. The successful candidate will be a strategic thinker, capable of driving continuous improvement in our quality systems. This role is linked to our pharmaceutical operations serving the **Kitale, Trans-Nzoia, KE** area.
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5
Lead Pharmaceutical Quality Assurance Specialist
Posted 12 days ago
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Job Description
Our client, a prominent player in the pharmaceutical industry, is searching for an experienced and meticulous Lead Pharmaceutical Quality Assurance Specialist. This critical role operates on a fully remote basis, offering the opportunity to influence quality standards and regulatory compliance across diverse pharmaceutical operations. You will be responsible for overseeing and implementing robust quality management systems, ensuring adherence to global regulatory standards (e.g., GMP, ISO). Your expertise will guide product development, manufacturing, and distribution processes, minimizing risks and maximizing product integrity.
Key Responsibilities:
This position demands a strong understanding of pharmaceutical manufacturing processes, quality control methodologies, and international regulatory landscapes. The successful candidate will possess exceptional analytical and problem-solving skills, with a keen eye for detail. As a remote leader, you must be highly organized, self-disciplined, and adept at remote collaboration. You will play a pivotal role in safeguarding the quality and safety of pharmaceutical products, contributing directly to patient well-being. This is a unique opportunity to lead quality initiatives within a globally recognized organization, working from a dedicated home office, impacting operations from Eldoret, Uasin Gishu, KE .
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) policies and procedures in line with regulatory requirements.
- Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers to ensure compliance.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA).
- Manage change control processes, ensuring all changes are properly assessed, documented, and implemented.
- Provide training and guidance to internal teams and external partners on QA principles and regulatory expectations.
- Monitor industry best practices and regulatory updates to ensure continuous improvement of the quality system.
- Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure quality is embedded throughout the product lifecycle.
- Prepare for and support regulatory inspections and customer audits.
This position demands a strong understanding of pharmaceutical manufacturing processes, quality control methodologies, and international regulatory landscapes. The successful candidate will possess exceptional analytical and problem-solving skills, with a keen eye for detail. As a remote leader, you must be highly organized, self-disciplined, and adept at remote collaboration. You will play a pivotal role in safeguarding the quality and safety of pharmaceutical products, contributing directly to patient well-being. This is a unique opportunity to lead quality initiatives within a globally recognized organization, working from a dedicated home office, impacting operations from Eldoret, Uasin Gishu, KE .
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Lead Pharmaceutical Quality Assurance Specialist
Posted 13 days ago
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Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Lead Pharmaceutical Quality Assurance Specialist to join their fully remote team. This crucial role ensures that all pharmaceutical products meet the highest standards of quality, safety, and efficacy in compliance with global regulatory requirements. You will be responsible for developing, implementing, and maintaining robust Quality Management Systems (QMS), leading quality audits, and driving continuous improvement initiatives. This position demands a meticulous approach, strong analytical skills, and excellent leadership capabilities.
Responsibilities:
Qualifications:
This is an outstanding opportunity to lead quality initiatives within a global pharmaceutical leader, working entirely remotely from Machakos, Machakos, KE , and significantly contribute to product integrity.
Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) in accordance with GMP, GCP, and GLP guidelines.
- Oversee and conduct internal and external quality audits to ensure compliance with regulatory standards and internal procedures.
- Review and approve critical documents, including batch records, validation protocols, and SOPs.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring timely and effective resolution.
- Manage product quality complaints and recalls, if necessary.
- Train and mentor QA team members and other personnel on quality standards and procedures.
- Liaise with regulatory agencies during inspections and audits.
- Monitor and report on key quality metrics and performance indicators to senior management.
- Stay current with evolving regulatory requirements and industry best practices.
- Drive continuous improvement initiatives within the quality assurance framework.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- A minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
- Proven experience in developing and implementing QMS.
- Strong experience in conducting and leading quality audits (internal and external).
- Excellent understanding of validation processes (IQ, OQ, PQ) and process validation.
- Proficiency in deviation management, CAPA systems, and change control procedures.
- Exceptional analytical, problem-solving, and decision-making skills.
- Outstanding written and verbal communication skills, with the ability to effectively communicate complex quality issues.
- Demonstrated leadership ability and experience managing teams is highly desirable.
- Experience in a remote work environment is a plus.
This is an outstanding opportunity to lead quality initiatives within a global pharmaceutical leader, working entirely remotely from Machakos, Machakos, KE , and significantly contribute to product integrity.
This advertiser has chosen not to accept applicants from your region.
7
Lead Pharmaceutical Quality Assurance Specialist
Posted 12 days ago
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Job Description
Our client is seeking a highly experienced Lead Pharmaceutical Quality Assurance Specialist to join their fully remote global team. This critical role will oversee and manage the quality assurance systems and processes for pharmaceutical product development and manufacturing, ensuring compliance with stringent regulatory standards. You will be instrumental in developing, implementing, and maintaining robust quality management systems (QMS) that adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant guidelines. The ideal candidate will possess a strong background in pharmaceutical sciences, quality control, and regulatory affairs. This is a fully remote position, allowing you to leverage your expertise from anywhere, supporting quality initiatives that impact pharmaceutical products distributed to regions including Kakamega, Kakamega, KE . Your responsibilities will include conducting internal audits, managing external audits, reviewing batch records, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPAs). You will also be responsible for validating quality control methods, ensuring the accuracy and reliability of laboratory data, and providing training to QA/QC personnel. Strong leadership, excellent attention to detail, and the ability to communicate complex quality-related issues effectively are essential. Experience with regulatory submissions and interactions with health authorities (e.g., FDA, EMA) is highly desirable. This role demands a proactive approach to quality management and a commitment to upholding the highest standards in the pharmaceutical industry.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Ensure compliance with GMP, GLP, and other applicable regulatory requirements.
- Conduct internal audits of manufacturing processes, facilities, and documentation.
- Manage and coordinate external audits by regulatory agencies and partners.
- Review and approve batch manufacturing records and quality control data.
- Investigate deviations, OOS results, and customer complaints, implementing CAPAs.
- Oversee the validation of analytical methods and equipment.
- Provide training and guidance to QA/QC staff and other departments on quality standards.
- Liaise with regulatory authorities during inspections and inquiries.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- 7+ years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of pharmaceutical quality systems, GMP, and regulatory requirements.
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Experience with regulatory submissions and inspections.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal skills.
- Ability to thrive in a remote work environment and manage multiple priorities.
This advertiser has chosen not to accept applicants from your region.
8
Lead Pharmaceutical Quality Assurance Specialist
Posted 9 days ago
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Job Description
Our client, a rapidly expanding pharmaceutical entity, is seeking an experienced Lead Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical role will involve overseeing and enhancing the quality management systems to ensure compliance with international pharmaceutical standards and regulatory requirements. You will be responsible for developing, implementing, and maintaining robust QA protocols, conducting internal audits, managing deviations and CAPAs (Corrective and Preventive Actions), and supporting external regulatory inspections. As a remote leader, you will collaborate closely with R&D, manufacturing, and regulatory affairs departments, leveraging advanced digital collaboration platforms to ensure alignment and effective communication. The ideal candidate will possess a strong scientific background in pharmaceuticals or a related field, extensive experience in GMP (Good Manufacturing Practices), ISO standards, and regulatory affairs, particularly within the pharmaceutical industry. Proficiency in quality management software and a keen eye for detail are essential. You will guide and mentor junior QA professionals, fostering a culture of quality excellence across the organization. This position offers the opportunity to make a significant impact on product quality and patient safety, working flexibly from your home office. We are looking for a proactive individual who can identify potential risks and implement mitigation strategies effectively, ensuring the integrity and compliance of all pharmaceutical products. Your expertise will be vital in maintaining the highest standards of quality assurance throughout the entire product lifecycle. The geographical focus for regulatory compliance and oversight will include operations impacting the region of **Mlolongo, Machakos, KE**, requiring an understanding of regional compliance nuances.
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