29 Senior Pharmaceutical Quality Assurance Specialist Remote jobs in whatjobs
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
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Job Description
Key responsibilities include:
- Developing, implementing, and maintaining the company's Quality Management System (QMS).
- Ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
- Conducting internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- Reviewing and approving batch records, validation protocols, and technical documentation.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPA).
- Participating in regulatory inspections and providing necessary documentation and support.
- Developing and delivering quality assurance training to relevant personnel.
- Monitoring and analyzing quality metrics to identify trends and areas for improvement.
- Contributing to product lifecycle management and change control processes.
- Staying up-to-date with evolving pharmaceutical regulations and industry best practices.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
Job Viewed
Job Description
Responsibilities:
- Ensure adherence to GMP, GLP, and other relevant pharmaceutical regulations.
- Develop, implement, and maintain Quality Management Systems (QMS).
- Conduct internal audits and support external regulatory inspections.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and OOS investigations.
- Validate manufacturing processes, analytical methods, and equipment.
- Review and approve batch records, specifications, and other quality-related documents.
- Write, revise, and implement SOPs and quality guidelines.
- Participate in change control procedures and risk assessments.
- Monitor and report on key quality metrics and performance indicators.
- Provide training to personnel on quality assurance principles and GMP compliance.
- Liaise with regulatory authorities and respond to queries.
- Contribute to the continuous improvement of quality processes.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements.
- Proven experience with audits, validation, and quality management systems.
- Strong understanding of pharmaceutical manufacturing processes and analytical techniques.
- Excellent documentation, investigation, and problem-solving skills.
- Proficiency in data analysis and interpretation.
- Strong communication and interpersonal skills, with the ability to present information clearly.
- Experience working in a remote or hybrid team environment is a plus.
- Proactive attitude towards identifying and resolving quality issues.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
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Job Description
You will be responsible for developing, implementing, and maintaining robust quality systems. This includes conducting internal audits, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPAs). The Senior QA Specialist will review and approve critical documentation, such as batch records, validation protocols, and SOPs. You will also play a key role in managing regulatory inspections and ensuring compliance with global health authority requirements (e.g., FDA, EMA). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated into all processes will be paramount. This position requires strong analytical skills, excellent problem-solving abilities, and meticulous attention to detail. As a fully remote role, exceptional self-management, communication, and proficiency in digital collaboration tools are essential. You will contribute significantly to the safety and efficacy of pharmaceutical products. Join a dedicated team committed to advancing healthcare through unwavering quality and compliance. While the company has operations in **Naivasha, Nakuru, KE**, this role is fully remote, offering significant flexibility and broad impact.
Responsibilities:
- Develop, implement, and maintain pharmaceutical quality assurance systems.
- Conduct internal audits and supplier audits to ensure compliance.
- Investigate deviations, OOS results, and customer complaints.
- Develop and implement CAPA plans.
- Review and approve critical quality documents (batch records, SOPs, validation protocols).
- Ensure compliance with GMP, GCP, and other relevant GXP regulations.
- Support regulatory inspections and respond to agency inquiries.
- Collaborate with cross-functional teams to maintain quality standards.
- Contribute to the continuous improvement of quality processes.
- Provide training on quality systems and regulatory requirements.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 7 years of experience in pharmaceutical quality assurance.
- In-depth knowledge of GMP, GCP, and other relevant GXP regulations.
- Proven experience with quality systems, audits, and investigations (deviations, CAPAs).
- Excellent analytical, problem-solving, and documentation skills.
- Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
- Exceptional communication and interpersonal abilities.
- Ability to work independently and manage responsibilities effectively in a remote environment.
Senior Pharmaceutical Quality Assurance Specialist - Remote
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Ensure compliance with all applicable regulatory requirements, including GMP, GDP, and ICH guidelines.
- Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- 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).
- Participate in regulatory inspections and prepare responses to regulatory queries.
- Develop and deliver quality assurance training programs to relevant personnel.
- Monitor and analyze quality metrics, providing reports on product quality and system performance.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
- Manage change control processes and ensure proper documentation and impact assessments.
- Stay up-to-date with evolving regulatory requirements and industry best practices.
- Contribute to the continuous improvement of quality systems and processes.
- Oversee the qualification and validation of equipment and processes.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 6 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Strong knowledge of pharmaceutical manufacturing processes and quality control.
- In-depth understanding of GMP, GLP, GDP, and other relevant regulatory guidelines.
- Experience in conducting internal and external audits.
- Excellent understanding of CAPA systems and change control processes.
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and accuracy.
- Excellent written and verbal communication skills.
- Ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
- Familiarity with quality management software is a plus.
- Experience supporting quality assurance for operations related to Garissa, Garissa, KE is beneficial.
This is a fully remote position. If you are a dedicated Quality Assurance professional seeking a challenging remote opportunity to uphold the highest pharmaceutical standards, we encourage you to apply.
Senior Pharmaceutical Quality Assurance Specialist - Remote
Posted 21 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP.
- Conduct internal audits of manufacturing processes, facilities, and systems.
- Investigate deviations, non-conformances, and out-of-specification results, ensuring root cause analysis and implementation of corrective and preventive actions (CAPA).
- Manage the change control process, assessing the impact of changes on product quality and regulatory compliance.
- Review and approve batch production records, ensuring adherence to established procedures.
- Monitor and ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA, WHO GMP).
- Prepare for and support regulatory inspections and client audits.
- Develop and deliver quality training programs to relevant personnel.
- Stay updated on industry best practices and changes in regulatory guidelines.
- Contribute to the validation of processes, equipment, and analytical methods.
- Collaborate with R&D, production, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Initiate and lead continuous improvement projects within the quality assurance framework.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree preferred.
- Minimum of 7 years of progressive experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, regulatory guidelines, and pharmaceutical manufacturing processes.
- Proven experience in conducting audits, managing deviations, and implementing CAPA.
- Strong understanding of validation principles and processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Meticulous attention to detail and strong documentation skills.
- Ability to work independently, manage multiple projects, and meet deadlines in a remote environment.
- Effective communication and interpersonal skills for collaboration with cross-functional teams.
- Experience with electronic QMS and document control systems is desirable.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
- Review and approve documentation, including batch records, validation protocols, SOPs, and change controls.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in regulatory inspections and respond to inquiries from health authorities.
- Develop and deliver quality training programs to relevant personnel.
- Monitor and analyze quality metrics, identifying trends and implementing continuous improvement initiatives.
- Contribute to the risk assessment process for new product development and manufacturing processes.
- Ensure that all pharmaceutical products are manufactured and tested according to approved procedures and specifications.
- Stay up-to-date with evolving regulatory requirements and industry best practices.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality standards are met throughout the product lifecycle.
- A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is preferred.
- Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
- Extensive knowledge of GMP, GLP, ICH guidelines, and other relevant pharmaceutical regulations (e.g., FDA, EMA).
- Proven experience in conducting audits, investigations, and implementing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and organizational abilities.
- Strong written and verbal communication skills, with the ability to clearly articulate complex quality issues.
- Proficiency in QMS software and Microsoft Office Suite.
- Ability to work independently and manage multiple projects effectively in a remote environment.
Senior Pharmaceutical Quality Assurance Specialist - Remote
Posted 21 days ago
Job Viewed
Job Description
Responsibilities:
- Oversee and maintain the Quality Management System (QMS) for pharmaceutical operations.
- Ensure compliance with cGMP, ICH, and other relevant regulatory guidelines.
- Conduct internal and external quality audits of suppliers and manufacturing sites.
- Review and approve batch production and control records.
- Investigate deviations, out-of-specification results, and customer complaints.
- Develop and implement corrective and preventive actions (CAPAs).
- Manage the validation of processes, equipment, and analytical methods.
- Review and approve documentation such as SOPs, protocols, and validation reports.
- Support regulatory inspections and submissions.
- Train and mentor junior QA personnel.
- Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of cGMP, ICH guidelines, and global pharmaceutical regulations.
- Experience with pharmaceutical manufacturing processes and quality control testing.
- Proficiency in quality risk management principles and tools.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with a high level of attention to detail.
- Demonstrated ability to work independently and manage multiple projects effectively in a remote environment.
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Senior Pharmaceutical Quality Assurance Specialist - Remote
Posted 21 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain Quality Assurance (QA) systems and procedures in compliance with cGMP, FDA, EMA, and other relevant regulatory requirements.
- Conduct internal and external audits of manufacturing facilities, suppliers, and vendors to ensure compliance.
- Review and approve batch production and control records, product release documentation, and stability data.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints, implementing corrective and preventative actions (CAPAs).
- Participate in the validation and qualification of manufacturing processes, equipment, and analytical methods.
- Prepare and present QA reports to management, highlighting quality metrics, trends, and areas for improvement.
- Collaborate with R&D, manufacturing, regulatory affairs, and other departments to ensure seamless product development and lifecycle management.
- Contribute to the development and execution of quality risk management strategies.
- Train personnel on quality systems and cGMP principles.
- Stay abreast of evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is a plus.
- A minimum of 6 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of cGMP regulations, ICH guidelines, and pharmaceutical quality systems.
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent documentation and technical writing skills.
- Exceptional analytical and problem-solving abilities.
- Strong interpersonal and communication skills, with experience working effectively in a remote team environment.
- Ability to manage multiple projects and priorities simultaneously.
- Experience with electronic quality management systems (eQMS) is advantageous.
This position is entirely remote, offering you the flexibility to work from your preferred location while contributing to quality standards that are conceptually aligned with the pharmaceutical landscape around **Kericho, Kericho, KE**. Join a dedicated team focused on ensuring the highest quality in pharmaceutical products.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 16 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain quality assurance systems and procedures in line with GxP regulations (GMP, GCP, GLP).
- Conduct internal and external audits of manufacturing facilities, suppliers, and contract research organizations.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Monitor and analyze quality metrics, identifying trends and areas for improvement.
- Prepare for and participate in regulatory inspections by agencies such as the FDA, EMA, and local health authorities.
- Ensure compliance with global pharmaceutical regulations and industry best practices.
- Provide quality oversight for product development, manufacturing, and lifecycle management.
- Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain.
- Manage change control processes to ensure that changes do not adversely impact product quality.
- Contribute to the continuous improvement of the quality management system.
- Effectively communicate quality requirements and expectations to internal and external stakeholders in a remote setting.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 6-8 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GxP regulations and pharmaceutical manufacturing processes.
- Proven experience in conducting and managing audits and regulatory inspections.
- Strong understanding of quality risk management principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex quality issues.
- Proficiency in quality management software and electronic document control systems.
- Demonstrated ability to work independently and manage responsibilities effectively in a remote work environment.
- Experience with cross-functional team collaboration in a remote setting is essential.
- Professional certifications in Quality Assurance (e.g., ASQ) are a plus.
This remote position supports our client's operations which are closely linked to **Embu, Embu, KE**, offering a critical role in ensuring the quality and safety of life-saving medications. If you are a dedicated QA professional passionate about maintaining the highest standards in the pharmaceutical industry, we encourage you to apply.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 15 days ago
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