85 Senior Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key responsibilities include:
- Developing, implementing, and maintaining Quality Management Systems (QMS) in accordance with cGMP, ICH, and other relevant guidelines.
- Conducting internal audits and supporting external regulatory inspections (e.g., FDA, EMA).
- Reviewing and approving batch records, validation protocols, and deviation reports.
- Managing change control processes and ensuring proper documentation.
- Investigating quality incidents, deviations, and customer complaints, and implementing corrective and preventive actions (CAPAs).
- Overseeing vendor qualification and quality agreements.
- Participating in product quality reviews and risk assessments.
- Providing training to personnel on quality assurance principles and procedures.
- Staying up-to-date with evolving regulatory requirements and industry best practices.
- Collaborating with manufacturing, R&D, and regulatory affairs teams to ensure seamless quality oversight.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A minimum of 5 years of experience in pharmaceutical quality assurance or quality control is required. Deep understanding of cGMP, GCP, and GLP principles is essential. Experience with regulatory inspections and audits is highly desirable. Strong analytical, problem-solving, and decision-making skills are critical for effective quality oversight. Excellent written and verbal communication skills are necessary for documentation and interdepartmental collaboration. The ability to work independently, manage multiple responsibilities, and maintain a high level of accuracy in a remote setting is paramount. Join our client in ensuring the safety and efficacy of pharmaceutical products, contributing to patient health for markets including Thika, Kiambu, KE .
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain Quality Assurance (QA) systems and procedures.
- Ensure compliance with cGMP, GLP, and other relevant regulatory standards.
- Conduct internal audits and inspections of manufacturing and laboratory operations.
- Review and approve batch records, validation documents, and change controls.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and out-of-specification (OOS) results.
- Participate in regulatory inspections and support external audits.
- Develop and deliver quality training programs to relevant personnel.
- Monitor and assess quality trends and recommend improvements.
- Collaborate with cross-functional teams to resolve quality issues.
- Stay current with evolving pharmaceutical regulations and industry best practices.
This is a fully remote position, providing excellent flexibility for qualified candidates. The operational scope covers pharmaceutical quality assurance for activities relevant to Kericho, Kericho, KE , and its broader market.
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory requirements.
- Conduct internal audits of various departments and processes to ensure adherence to GMP, GCP, and other standards.
- Participate in external audits by regulatory agencies and customers.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Manage change control processes and risk assessments.
- Provide training to personnel on quality assurance procedures and regulatory requirements.
- Monitor industry trends and regulatory updates to ensure ongoing compliance.
- Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
- Maintain accurate and organized quality records.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is preferred.
- Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant pharmaceutical regulations.
- Experience with auditing processes and performing quality risk assessments.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and documentation skills.
- Effective communication and interpersonal skills, with the ability to collaborate across departments.
- Proficiency in quality management software and MS Office Suite.
- Ability to work independently and manage time effectively in a remote environment.
This is an exceptional opportunity for a dedicated QA professional to contribute to a leading pharmaceutical organization while enjoying the flexibility of a fully remote role. Our client values expertise and provides a supportive remote work culture. If you are passionate about ensuring the quality and safety of life-saving medicines, apply today. This role, though remote, is associated with the regulatory environment of **Garissa, Garissa, KE**.
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with relevant pharmaceutical regulations (e.g., GMP, ICH guidelines).
- Conduct internal audits and assessments of manufacturing processes, documentation, and facilities to ensure compliance.
- Review and approve critical quality-related documents, including batch records, validation protocols, and SOPs.
- Manage and oversee deviation investigations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
- Support external regulatory inspections and client audits, ensuring preparedness and successful outcomes.
- Provide training to personnel on GMP requirements, quality procedures, and best practices.
- Monitor and analyze quality metrics, identifying trends and recommending proactive measures to prevent quality issues.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
- Stay current with evolving pharmaceutical regulations and industry standards.
- Contribute to the continuous improvement of quality processes and systems.
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical quality assurance or quality control, with a strong understanding of GMP regulations.
- Proven experience in developing and managing QMS, conducting audits, and handling regulatory inspections.
- In-depth knowledge of pharmaceutical manufacturing processes and analytical testing methods.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong documentation and technical writing abilities.
- Exceptional attention to detail and commitment to accuracy.
- Effective communication and interpersonal skills for remote collaboration.
- Proficiency in using quality management software and tools.
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain a comprehensive Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
- Conduct internal audits of manufacturing processes, facilities, and documentation to ensure compliance.
- Participate in external audits and inspections by regulatory agencies (e.g., FDA, EMA).
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Monitor and analyze quality metrics, identifying trends and recommending improvements to quality processes.
- Manage change control processes for products, processes, and equipment.
- Train personnel on quality assurance procedures, cGMP principles, and regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated throughout the product lifecycle.
- Evaluate and approve raw material suppliers and contract manufacturers.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Lead and mentor junior QA team members.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.).
- Proven experience in developing and implementing QMS, conducting audits, and managing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and product development.
- Excellent analytical, problem-solving, and decision-making skills.
- Meticulous attention to detail and a commitment to accuracy.
- Exceptional written and verbal communication skills.
- Ability to work independently and collaboratively in a remote team environment.
- Experience with quality control testing and instrumentation is a plus.
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Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) for pharmaceutical operations.
- Ensure compliance with GMP, GDP, and other applicable regulatory guidelines (e.g., FDA, EMA).
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch manufacturing records, analytical test results, and stability data.
- Investigate deviations, OOS results, and customer complaints, implementing CAPA.
- Manage change control processes to assess and implement changes to processes, materials, or equipment.
- Participate in supplier qualification and audits.
- Provide QA oversight for product development and lifecycle management.
- Train personnel on quality assurance procedures and regulatory requirements.
- Prepare and review quality-related documentation, including SOPs, policies, and validation protocols.
- Monitor regulatory intelligence and ensure the QMS remains up-to-date.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 6 years of progressive experience in Pharmaceutical Quality Assurance or Quality Control.
- Extensive knowledge of GMP, GDP, and other relevant pharmaceutical regulations.
- Proven experience in auditing, deviation management, and CAPA implementation.
- Familiarity with pharmaceutical manufacturing processes and analytical testing.
- Excellent written and verbal communication skills, with the ability to document complex information clearly.
- Strong analytical, problem-solving, and critical thinking skills.
- Proficiency in quality management software and standard office applications.
- Ability to work independently, manage multiple priorities, and meet deadlines in a remote environment.
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain robust Quality Assurance (QA) systems and procedures.
- Conduct internal audits and inspections to ensure compliance with cGMP and other relevant regulations.
- Review and approve batch records, analytical data, and validation reports.
- Manage deviation investigations, root cause analysis, and Corrective and Preventive Actions (CAPA).
- Oversee the qualification and validation of equipment and processes.
- Collaborate with R&D and Production teams to ensure product quality from development to commercialization.
- Prepare for and participate in regulatory inspections (e.g., FDA, EMA).
- Stay current with evolving regulatory requirements and industry best practices.
- Develop and deliver QA training programs for relevant personnel.
- Contribute to the continuous improvement of quality processes and overall compliance.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. Master's degree preferred.
- Minimum of 7 years of experience in Pharmaceutical Quality Assurance/Quality Control.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Experience with regulatory submissions and inspections.
- Proficiency in quality management software and tools.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent documentation and communication abilities, both written and verbal.
- Proven ability to work independently and manage multiple projects in a remote environment.
- Experience in sterile manufacturing or biologics is a plus.
- Strong understanding of risk management principles.
Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
Job Viewed
Job Description
Key responsibilities include conducting internal audits, overseeing external audits, and managing deviations and corrective/preventive actions (CAPAs). You will be instrumental in reviewing and approving batch records, validation protocols, and change controls. This position requires a thorough understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. The ideal candidate will possess exceptional analytical skills, a meticulous approach to documentation, and the ability to identify potential quality risks and propose effective solutions. You will collaborate with various departments, including R&D, manufacturing, and regulatory affairs, to uphold the highest standards of quality.
Essential qualifications include a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is an advantage. A minimum of 7 years of progressive experience in pharmaceutical quality assurance or quality control is mandatory. In-depth knowledge of regulatory guidelines from bodies such as the FDA, EMA, and local Kenyan authorities is crucial. Experience with risk management principles and deviation investigations is required. Excellent written and verbal communication skills, strong problem-solving abilities, and proficiency in QMS software are essential. This is an excellent opportunity for a dedicated QA professional to drive quality excellence in the pharmaceutical industry from a remote setting, significantly contributing to patient safety and product integrity.