11 Pharmaceutical Quality Assurance Manager jobs in whatjobs
Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is seeking a highly qualified and experienced Pharmaceutical Quality Assurance Manager to lead their quality systems and compliance efforts within a fully remote framework. This crucial role ensures that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems, including SOPs, batch record review, deviation management, CAPA, change control, and internal audits. Key responsibilities include ensuring compliance with cGMP, FDA, and other relevant regulatory guidelines. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. Strong leadership, analytical, and problem-solving skills are essential. As this is a fully remote position, exceptional written and verbal communication skills are paramount for effective collaboration with manufacturing teams, R&D, and regulatory bodies across different locations. You must be self-motivated, detail-oriented, and capable of managing multiple complex projects with a high degree of accuracy. This role offers the significant opportunity to ensure the safety and efficacy of pharmaceutical products while working flexibly from anywhere. You will play a critical role in maintaining the integrity of the company's quality operations and fostering a culture of continuous quality improvement. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required. A Master's degree or relevant professional certifications are advantageous. A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and quality control, with a significant portion in a management or supervisory role, is essential. Experience with electronic quality management systems is a plus. This position is fully remote, supporting quality assurance operations that may be connected to Mombasa, Mombasa, KE . If you are a seasoned QA professional dedicated to upholding the highest standards in the pharmaceutical industry, we encourage you to apply.
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Pharmaceutical Quality Assurance Manager
Posted 21 days ago
Job Viewed
Job Description
Our client, a leader in pharmaceutical innovation, is seeking a dedicated and experienced Pharmaceutical Quality Assurance Manager to oversee quality systems and ensure compliance within a fully remote framework. This role is pivotal in maintaining the highest standards of product safety and efficacy.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with cGMP, FDA, and other relevant regulatory guidelines.
- Conduct internal audits and inspections to assess adherence to quality standards and identify areas for improvement.
- Manage external audits and inspections by regulatory authorities and partners.
- Oversee the review and approval of batch records, validation protocols, and change controls.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and customer complaints, ensuring timely and effective resolutions.
- Develop and deliver quality assurance training programs for relevant personnel.
- Monitor and analyze quality metrics and trends to identify systemic issues and opportunities for process enhancement.
- Ensure that all pharmaceutical manufacturing and laboratory operations meet required quality standards.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure product quality throughout the lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Manage the quality review process for new product introductions and lifecycle management.
- Lead continuous improvement initiatives within the quality assurance function.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
- Minimum of 6 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
- Proven experience in developing and implementing QMS, conducting audits, and managing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and regulatory bodies.
- Demonstrated leadership capabilities and the ability to work independently in a remote environment.
- Proficiency in quality management software and tools.
- Attention to detail and a commitment to maintaining the highest quality standards.
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Pharmaceutical Quality Assurance Manager
Posted 19 days ago
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Job Description
Our client is looking for a highly experienced and meticulous Pharmaceutical Quality Assurance Manager to lead their quality control and assurance initiatives within a fully remote setting. This senior role is crucial for ensuring that all pharmaceutical products meet rigorous quality standards and regulatory compliance requirements. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) across all operations. Your duties will include overseeing batch record reviews, deviation investigations, change control processes, and CAPA (Corrective and Preventive Actions) implementation. The ideal candidate will possess a comprehensive understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant pharmaceutical regulations. You will conduct internal audits and support external regulatory inspections to ensure ongoing compliance. Collaboration with R&D, manufacturing, and regulatory affairs departments is essential to embed a culture of quality throughout the organization. This is a remote-first position, requiring exceptional leadership, analytical, and problem-solving skills, as well as the ability to manage complex projects and teams virtually. You will be responsible for training staff on quality procedures and ensuring adherence to established protocols. Strong documentation skills and the ability to interpret and apply complex regulatory guidelines are paramount. This is an exceptional opportunity for a dedicated QA professional to drive excellence in pharmaceutical quality and ensure the safety and efficacy of our client's products from a remote work environment. The role is associated with **Embu, Embu, KE**, but is a fully remote position.
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Pharmaceutical Quality Assurance Manager
Posted 19 days ago
Job Viewed
Job Description
Our client, a well-established pharmaceutical company, is seeking a diligent and experienced Pharmaceutical Quality Assurance Manager to oversee their quality systems. This critical role ensures that all products meet rigorous regulatory standards and internal quality benchmarks. You will lead a team responsible for developing, implementing, and maintaining comprehensive quality assurance programs across manufacturing, research, and development. Your expertise will be vital in upholding the integrity and safety of our pharmaceutical products.
Key responsibilities will include:
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 7 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial role, is required. Strong knowledge of pharmaceutical regulations (e.g., FDA, EMA) and quality standards is essential. Excellent leadership, analytical, problem-solving, and communication skills are necessary. This role requires a hybrid work arrangement, blending remote flexibility with essential on-site collaboration in Mombasa, Mombasa, KE .
Key responsibilities will include:
- Developing and implementing Quality Management Systems (QMS) in accordance with GMP, GCP, and other relevant regulatory guidelines.
- Leading and managing the QA team, providing guidance and fostering professional development.
- Overseeing internal and external audits, ensuring compliance with regulatory requirements.
- Managing deviation investigations, CAPA implementation, and change control processes.
- Reviewing and approving batch records, validation protocols, and other critical quality documentation.
- Conducting risk assessments and implementing mitigation strategies to ensure product quality and patient safety.
- Collaborating with cross-functional teams (Manufacturing, R&D, Regulatory Affairs) to resolve quality issues.
- Ensuring that all quality-related training programs are effective and up-to-date.
- Monitoring industry trends and regulatory changes to ensure ongoing compliance.
- Representing the QA department during regulatory inspections.
- Driving continuous improvement initiatives within the quality function.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 7 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial role, is required. Strong knowledge of pharmaceutical regulations (e.g., FDA, EMA) and quality standards is essential. Excellent leadership, analytical, problem-solving, and communication skills are necessary. This role requires a hybrid work arrangement, blending remote flexibility with essential on-site collaboration in Mombasa, Mombasa, KE .
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Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Job Description
Our client is seeking a highly experienced and detail-oriented Pharmaceutical Quality Assurance Manager to join their team. This position will be a hybrid role, requiring a balance of remote work and on-site presence at our **Kisumu, Kisumu, KE** facility. The ideal candidate will possess a deep understanding of Good Manufacturing Practices (GMP), regulatory compliance, and quality management systems within the pharmaceutical industry. You will be responsible for developing, implementing, and maintaining robust quality assurance programs to ensure the safety, efficacy, and consistency of our pharmaceutical products. Key responsibilities include overseeing quality control processes, conducting internal audits, managing deviation investigations, implementing corrective and preventive actions (CAPA), and ensuring compliance with national and international regulatory standards (e.g., FDA, EMA). You will also play a crucial role in qualifying suppliers and third-party manufacturers. The successful applicant will have excellent analytical and problem-solving skills, strong leadership capabilities, and the ability to effectively communicate quality standards and requirements to all levels of the organization. This is a vital role in upholding the integrity and reputation of our pharmaceutical operations.
Responsibilities:
Responsibilities:
- Develop and implement comprehensive Quality Assurance (QA) programs and policies.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory requirements.
- Oversee all quality control activities, including raw material testing, in-process testing, and finished product release.
- Conduct internal audits and inspections to assess compliance and identify areas for improvement.
- Manage deviation investigations and implement effective Corrective and Preventive Actions (CAPA).
- Qualify and monitor suppliers and contract manufacturing organizations.
- Review and approve batch records, validation protocols, and reports.
- Provide QA support for product development, scale-up, and commercial manufacturing.
- Train and mentor QA/QC staff.
- Stay updated on regulatory changes and industry best practices.
- Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP, regulatory affairs, and quality management systems.
- Proven experience in conducting audits, investigations, and implementing CAPA.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to work effectively both remotely and on-site.
- Familiarity with validation processes (process, cleaning, analytical method).
- Experience with regulatory inspections is highly desirable.
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Pharmaceutical Quality Assurance Manager
Posted 18 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and meticulous Pharmaceutical Quality Assurance Manager to oversee and ensure compliance with stringent quality standards. This is a fully remote position, offering a unique opportunity to manage quality operations from anywhere. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) across all pharmaceutical processes, from research and development to manufacturing and distribution. The ideal candidate will have a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements (e.g., FDA, EMA). Your expertise will be crucial in conducting internal audits, managing external audits, investigating deviations, implementing corrective and preventive actions (CAPA), and ensuring product quality and safety. Strong leadership, analytical, and problem-solving skills are essential, along with the ability to interpret complex regulatory guidelines and translate them into actionable quality procedures. Excellent written and verbal communication skills are required for interacting with regulatory bodies, internal teams, and external partners. This role requires a detail-oriented professional with a commitment to continuous improvement and a proactive approach to risk management. This is a fully remote opportunity, offering significant flexibility. Our client is dedicated to supporting its remote workforce with the necessary tools and resources for success. If you are an experienced QA professional with a passion for pharmaceutical quality and a desire to lead in a remote capacity, we encourage you to apply. Join us and play a critical role in ensuring the highest standards of quality and compliance in the pharmaceutical industry.
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Pharmaceutical Quality Assurance Manager
Posted 11 days ago
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Job Description
Our client, a highly respected pharmaceutical company dedicated to producing safe and effective medications, is seeking an experienced Pharmaceutical Quality Assurance Manager to uphold the highest standards of quality throughout their operations. This is a fully remote position, allowing you to drive quality initiatives from anywhere. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, WHO GMP). Your role will involve overseeing all quality assurance activities, including batch record review, deviation management, change control, CAPA (Corrective and Preventive Actions) implementation, internal and external audits, and supplier qualification. We are looking for a candidate with a strong background in pharmaceutical quality assurance, a deep understanding of GMP principles, and a meticulous attention to detail. Excellent leadership, analytical, and problem-solving skills are essential, as you will be responsible for ensuring product quality, patient safety, and regulatory compliance. Experience in sterile manufacturing, biologics, or other specialized pharmaceutical areas is a significant advantage. The ideal candidate will be a proactive leader, a strong communicator, and a collaborative team player who can effectively manage a remote QA team and interact with various departments, including R&D, manufacturing, regulatory affairs, and supply chain. This role offers a crucial opportunity to ensure the integrity and quality of life-saving medicines. Your expertise will be vital in maintaining the company's reputation and its commitment to excellence.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and manage the Pharmaceutical Quality Management System (QMS).
- Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Oversee batch record review and release processes.
- Manage deviation investigations, change controls, and CAPA systems.
- Plan and conduct internal audits and support external regulatory inspections.
- Qualify and monitor suppliers and contract manufacturers.
- Develop and deliver quality training programs.
- Lead and mentor the Quality Assurance team.
- Contribute to continuous improvement initiatives within the quality systems.
- Stay abreast of regulatory changes and industry best practices.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical Quality Assurance.
- In-depth knowledge of GMP regulations and quality systems in the pharmaceutical industry.
- Proven experience in managing QA operations and teams.
- Experience with regulatory submissions and inspections (e.g., FDA, EMA).
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills.
- Ability to work independently and manage remote team members.
- Experience with various pharmaceutical manufacturing processes.
- Proficiency in quality management software and tools.
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Pharmaceutical Quality Assurance Manager
Posted 4 days ago
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Job Description
Our client, a reputable pharmaceutical company, is seeking a highly experienced Pharmaceutical Quality Assurance Manager. This role operates on a hybrid model, requiring your presence in our Malindi, Kilifi, KE office periodically, while also offering remote flexibility. You will be responsible for establishing and maintaining a robust quality management system (QMS) to ensure compliance with all relevant regulatory standards, including GMP (Good Manufacturing Practices). Your core duties will involve developing, implementing, and overseeing quality control procedures, conducting internal audits, managing deviations and CAPAs (Corrective and Preventive Actions), and ensuring the quality of raw materials, in-process products, and finished goods. The ideal candidate will possess a strong background in pharmaceutical sciences, chemistry, or a related field, coupled with significant experience in quality assurance within the pharmaceutical industry. A deep understanding of regulatory affairs, quality systems, and validation processes is essential. You must demonstrate strong leadership, analytical, and problem-solving skills. Excellent communication and documentation abilities are crucial for interacting with regulatory bodies, internal departments, and external partners. Experience with quality risk management and change control processes is highly desirable. This position offers a challenging and rewarding opportunity to safeguard product quality and ensure patient safety, contributing significantly to the company's reputation and success. Join our team and play a pivotal role in upholding the highest standards of quality in pharmaceutical manufacturing. The job is located in Malindi, Kilifi, KE .
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Pharmaceutical Quality Assurance Manager
Posted 5 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical organization, is seeking a highly experienced and meticulous Pharmaceutical Quality Assurance Manager to lead their quality systems and compliance efforts. This role is designed to be fully remote, offering unparalleled flexibility while ensuring the highest standards of quality are maintained across all operations. The successful candidate will be instrumental in developing, implementing, and maintaining robust quality management systems (QMS) that align with global regulatory requirements. You will oversee audits, investigations, and continuous improvement initiatives, ensuring that all pharmaceutical products meet stringent quality and safety benchmarks. This position demands a deep understanding of pharmaceutical manufacturing processes, regulatory guidelines (e.g., GMP, ICH), and quality control principles.
Key Responsibilities:
This role requires exceptional leadership, analytical, and problem-solving skills. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field, with extensive experience in pharmaceutical quality assurance. Proficiency in quality management software and a thorough understanding of regulatory documentation are crucial. As a fully remote position, strong self-discipline, excellent communication skills, and the ability to manage projects autonomously are essential. You will be expected to collaborate effectively with cross-functional teams across different time zones. Our client is dedicated to producing high-quality pharmaceuticals and seeks a proactive leader to uphold their commitment to excellence.
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Oversee all quality assurance activities, including internal and external audits.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards.
- Manage the investigation of deviations, out-of-specification (OOS) results, and customer complaints.
- Develop and implement corrective and preventive actions (CAPAs).
- Review and approve batch records, validation protocols, and other quality-related documents.
- Lead and mentor the QA team, fostering a culture of quality and compliance.
- Interface with regulatory agencies during inspections and audits.
- Conduct risk assessments and implement risk mitigation strategies.
- Drive continuous improvement initiatives within the quality assurance function.
This role requires exceptional leadership, analytical, and problem-solving skills. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field, with extensive experience in pharmaceutical quality assurance. Proficiency in quality management software and a thorough understanding of regulatory documentation are crucial. As a fully remote position, strong self-discipline, excellent communication skills, and the ability to manage projects autonomously are essential. You will be expected to collaborate effectively with cross-functional teams across different time zones. Our client is dedicated to producing high-quality pharmaceuticals and seeks a proactive leader to uphold their commitment to excellence.
This advertiser has chosen not to accept applicants from your region.
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Pharmaceutical Quality Assurance Manager
Posted 6 days ago
Job Viewed
Job Description
Our client, a rapidly growing pharmaceutical company dedicated to improving global health outcomes, is seeking an experienced and detail-oriented Pharmaceutical Quality Assurance Manager to join our fully remote operations. This critical role ensures that all pharmaceutical products meet stringent quality standards, regulatory requirements, and company policies throughout their lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems (QMS), conducting internal audits, and managing external regulatory inspections. The ideal candidate will possess a strong background in pharmaceutical sciences, regulatory affairs, and quality assurance, with a deep understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant industry standards. You will work remotely, collaborating closely with R&D, manufacturing, supply chain, and regulatory affairs teams to uphold the highest levels of product quality and compliance. Key responsibilities include reviewing and approving batch records, managing deviations and CAPAs (Corrective and Preventive Actions), and overseeing change control processes. We are looking for an individual with exceptional analytical skills, strong leadership capabilities, and a commitment to ensuring patient safety and product efficacy. This role requires meticulous record-keeping, excellent communication, and the ability to effectively communicate complex quality issues to diverse stakeholders. Your expertise will be invaluable in maintaining our company's reputation for excellence and ensuring compliance with national and international pharmaceutical regulations. This is a significant opportunity to contribute to pharmaceutical quality from **Garissa, Garissa, KE**, in a fully remote capacity.
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