6 Senior Pharmaceutical Quality Assurance Specialist Remote jobs in whatjobs
Senior Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dynamic team in Mombasa, Mombasa, KE . This role will play a critical part in ensuring the highest standards of quality and compliance throughout the pharmaceutical product lifecycle, from research and development to manufacturing and distribution. The ideal candidate will possess a deep understanding of regulatory requirements and a passion for maintaining product integrity.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with national and international pharmaceutical regulations (e.g., GMP, ICH guidelines).
- Conduct internal and external audits of manufacturing facilities, suppliers, and contract manufacturers to assess compliance and identify areas for improvement.
- Review and approve batch records, validation protocols, and technical documentation to ensure accuracy and adherence to specifications.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Manage the change control process, evaluating the impact of proposed changes on product quality and regulatory compliance.
- Develop and deliver training programs on quality assurance principles and GMP practices to relevant personnel.
- Monitor and analyze quality metrics, identifying trends and providing reports to management to drive continuous improvement initiatives.
- Participate in regulatory inspections and respond to inquiries from health authorities.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless integration of quality processes.
- Contribute to the continuous improvement of QA processes and procedures, seeking efficiencies and enhancing overall quality performance.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is preferred.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP regulations, quality control principles, and pharmaceutical manufacturing processes.
- Proven experience in conducting audits, managing CAPAs, and handling change control.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to effectively present complex information.
- Experience with regulatory submissions and interactions with health authorities.
- Proficiency in relevant software, including QMS databases and statistical analysis tools.
- Ability to work effectively both independently and as part of a cross-functional team.
- Demonstrated leadership potential and a commitment to ethical practices.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their esteemed team on a fully remote basis. This critical 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 quality management systems, conducting audits, and ensuring compliance with cGMP, ICH guidelines, and other relevant regulations. As a remote professional, you will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, utilizing advanced digital communication tools to maintain oversight and drive quality initiatives. The ideal candidate possesses a deep understanding of pharmaceutical quality systems and a meticulous attention to detail.
Responsibilities:
Qualifications:
This is an exceptional opportunity for a seasoned QA professional to contribute significantly to patient safety and product quality in a fully remote capacity, based in **Mombasa, Mombasa, KE**. Join a progressive organization that values expertise, dedication, and the well-being of its remote workforce.
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPA (Corrective and Preventive Actions).
- Ensure compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
- Participate in regulatory inspections and respond to regulatory inquiries.
- Develop and deliver quality training programs to relevant personnel.
- Monitor key quality metrics and provide regular reports to management.
- Stay updated on evolving regulatory requirements and industry best practices.
- Contribute to the continuous improvement of quality processes and systems.
- Oversee change control processes and risk assessments.
- Manage documentation control processes to ensure accuracy and accessibility.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5 years of experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant regulatory standards.
- Proven experience in conducting audits and managing QMS.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in documentation review and investigation processes.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
- Experience with electronic QMS is a plus.
- Must be legally authorized to work in Kenya.
This is an exceptional opportunity for a seasoned QA professional to contribute significantly to patient safety and product quality in a fully remote capacity, based in **Mombasa, Mombasa, KE**. Join a progressive organization that values expertise, dedication, and the well-being of its remote workforce.
This advertiser has chosen not to accept applicants from your region.
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Senior Pharmaceutical Quality Assurance Specialist
Posted 9 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator committed to advancing global health, is seeking a highly qualified Senior Pharmaceutical Quality Assurance Specialist to join their distinguished remote team. This critical role is responsible for upholding the highest standards of quality and compliance in pharmaceutical product development and manufacturing, all managed through a distributed operational model. You will conduct thorough reviews of batch records, investigate deviations and out-of-specification results, and contribute to the continuous improvement of quality systems. The ideal candidate will possess an extensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements from authorities such as the Pharmacy and Poisons Board. Your expertise will be vital in ensuring that all pharmaceutical products meet stringent safety, efficacy, and quality benchmarks. This position requires meticulous attention to detail, strong analytical skills, and the ability to interpret complex scientific data. You will be instrumental in developing and implementing quality control strategies, conducting internal audits, and managing vendor quality agreements. This role operates entirely remotely, demanding excellent communication skills and the ability to collaborate effectively with cross-functional teams across different geographical locations. You will be a key player in risk assessment and mitigation activities, ensuring proactive identification and resolution of potential quality issues. The successful candidate will demonstrate a proactive approach to quality management and a commitment to maintaining a culture of excellence. We are looking for an individual who thrives in a remote work setting and is passionate about contributing to the development of life-saving medicines. If you are an experienced QA professional with a deep background in pharmaceuticals and a desire to make a significant impact remotely, we encourage you to apply.
Responsibilities:
Responsibilities:
- Ensure adherence to Good Manufacturing Practices (GMP) and other relevant quality standards.
- Review and approve batch manufacturing records and quality control data.
- Investigate deviations, out-of-specifications, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in internal and external audits, and support regulatory inspections.
- Develop and maintain Standard Operating Procedures (SOPs) and other quality-related documentation.
- Conduct risk assessments and implement mitigation strategies for quality-related issues.
- Qualify and monitor contract manufacturers and suppliers.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality.
- Contribute to the continuous improvement of the Quality Management System (QMS).
- Provide training and guidance to junior QA staff on quality principles and practices.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of experience in pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of GMP, GLP, and regulatory requirements in the pharmaceutical industry.
- Experience with pharmaceutical product development lifecycle.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to manage multiple tasks and projects simultaneously in a remote setting.
- Experience with electronic QMS and data management systems is a plus.
- Must be legally authorized to work in Kenya.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their globally distributed team. This is a fully remote position, offering the flexibility to contribute your expertise from anywhere. You will be responsible for ensuring that all pharmaceutical products meet rigorous quality standards and comply with regulatory requirements (e.g., FDA, EMA, WHO GMP). Your duties will include developing and implementing quality management systems, conducting internal and external audits, reviewing batch records, and investigating deviations and non-conformances. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing processes, quality control, and regulatory affairs. You will play a critical role in maintaining the integrity and safety of our client's pharmaceutical products. This position requires excellent attention to detail, strong analytical skills, and the ability to interpret complex regulatory guidelines. You will collaborate with various departments, including R&D, manufacturing, and regulatory affairs, to ensure a unified approach to quality. This is an excellent opportunity for a dedicated QA professional who thrives in a remote work environment and is passionate about upholding the highest standards in the pharmaceutical industry. You will be expected to contribute to continuous improvement initiatives and to stay current with evolving regulatory landscapes. Your role is crucial in safeguarding public health by ensuring the quality and efficacy of the medicines we produce.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) for pharmaceutical products.
- Conduct internal audits to ensure compliance with GMP, ISO, and other relevant standards.
- Participate in external audits and regulatory inspections.
- Review and approve batch manufacturing records (BMRs) and analytical test results.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Implement and manage CAPA (Corrective and Preventive Actions) plans.
- Develop and deliver quality-related training to personnel.
- Ensure compliance with all applicable regulatory requirements.
- Manage vendor qualification and auditing processes.
- Oversee change control procedures and documentation.
- Contribute to the validation of equipment, processes, and analytical methods.
- Prepare and submit regulatory documentation as required.
- Monitor industry trends and regulatory updates relevant to pharmaceutical quality.
- Champion a culture of quality and continuous improvement throughout the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP (Good Manufacturing Practices) regulations.
- Experience with ICH guidelines and other international regulatory requirements.
- Proven experience in conducting audits and managing deviations.
- Strong understanding of pharmaceutical manufacturing processes and quality control testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in documentation and record-keeping.
- Strong written and verbal communication skills.
- Ability to work independently and manage priorities effectively in a remote setting.
- Experience with quality risk management principles.
- Relevant certifications (e.g., CQE) are a plus.
This advertiser has chosen not to accept applicants from your region.
3
Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking an experienced Senior Pharmaceutical Quality Assurance Specialist to join their global, fully remote team. This pivotal role will be instrumental in ensuring the highest standards of quality and compliance across all pharmaceutical products and processes. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal audits, and managing external regulatory inspections. The ideal candidate possesses a deep understanding of GMP (Good Manufacturing Practices), GXP (Good Practices), and relevant international pharmaceutical regulations. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to translate complex regulatory requirements into actionable quality control strategies. You will collaborate virtually with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product integrity from development through to market release. The ability to work autonomously in a remote environment, manage critical documentation, and contribute to continuous improvement initiatives is essential. You will play a key role in ensuring our client's products meet stringent global quality benchmarks, safeguarding patient safety and company reputation. This is a unique opportunity for a seasoned QA professional to make a significant impact on the quality and compliance framework of a forward-thinking pharmaceutical organization, all from the comfort of their home office. Your expertise will guide product lifecycle quality, from early-stage development through post-market surveillance, ensuring every stage adheres to the strictest pharmaceutical standards. The successful candidate will be a champion for quality, driving best practices and fostering a culture of excellence throughout the organization, ensuring all products meet and exceed global regulatory and safety standards.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal audits and inspections of manufacturing processes, laboratories, and documentation.
- Manage and coordinate external regulatory inspections (e.g., FDA, EMA) and customer audits.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Provide quality assurance support for product development, manufacturing, and lifecycle management.
- Ensure compliance with relevant pharmaceutical regulations, guidelines, and standards (GMP, GXP, ICH).
- Train personnel on quality assurance principles and regulatory requirements.
- Contribute to continuous improvement initiatives within the Quality Unit.
- Act as a key liaison between the company and regulatory bodies.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree preferred.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, GXP, and other relevant pharmaceutical regulations and guidelines.
- Experience with auditing, deviation management, and CAPA systems.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to work independently and manage multiple priorities in a remote setting.
- Familiarity with pharmaceutical manufacturing processes and technologies.
- Experience with regulatory submissions and interactions is a plus.
- Detail-oriented and committed to upholding the highest quality standards.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company committed to developing life-saving medicines, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist. This is a fully remote position, allowing you to contribute your expertise to ensure the highest standards of quality and compliance in drug development and manufacturing from anywhere. You will be responsible for establishing and maintaining robust quality systems, conducting audits, and ensuring adherence to regulatory requirements.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance systems in accordance with cGMP, GCP, and relevant international guidelines.
- Conduct internal and external audits of manufacturing facilities, contract manufacturers, and suppliers.
- Review and approve batch records, validation reports, and other quality-critical documents.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
- Participate in regulatory inspections and respond to queries from health authorities.
- Develop and deliver quality training programs to personnel involved in pharmaceutical operations.
- Monitor and evaluate product quality and manufacturing processes, identifying areas for improvement.
- Stay updated on evolving regulatory requirements and industry best practices.
- Contribute to the risk management process and ensure its effective implementation.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
- Lead quality investigations and root cause analysis for quality events.
- Prepare and present quality metrics and reports to senior management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practices), and relevant regulatory guidelines (e.g., FDA, EMA).
- Proven experience in conducting audits and managing quality systems.
- Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Exceptional written and verbal communication skills, with the ability to document complex findings clearly and concisely.
- Ability to work independently and manage multiple priorities in a remote setting.
- Experience with validation protocols and IQ/OQ/PQ is highly desirable.
- Strong attention to detail and commitment to maintaining the highest quality standards.
This advertiser has chosen not to accept applicants from your region.
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