6,649 Senior Pharmaceutical Quality Assurance Specialist Remote jobs in Kenya
Senior Pharmaceutical Quality Assurance Analyst - Remote
Posted 20 days ago
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Key responsibilities will involve conducting in-depth reviews of batch records, analytical data, and validation reports to ensure accuracy, completeness, and compliance. You will be responsible for investigating deviations, out-of-specification (OOS) results, and customer complaints, performing root cause analysis, and recommending corrective and preventive actions (CAPAs). This role requires significant interaction with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure quality is integrated throughout the product lifecycle. You will also participate in internal and external audits, providing support and ensuring readiness for regulatory inspections.
Furthermore, the Senior Pharmaceutical Quality Assurance Analyst will contribute to the development and improvement of quality management systems, standard operating procedures (SOPs), and training programs. You will be expected to stay abreast of evolving regulatory landscapes and industry best practices, providing guidance and expertise to project teams. A key aspect of this role involves risk assessment and management related to product quality and manufacturing processes. The ability to manage multiple projects simultaneously, meet strict deadlines, and maintain a high level of detail is essential. This remote position requires strong analytical, critical thinking, and communication skills. While the role is remote, a deep understanding of pharmaceutical operations, including those potentially serving the **Machakos, Machakos, KE** region or similar, is vital for context and effective collaboration.
Remote Pharmaceutical Quality Assurance Specialist (Remote)
Posted 22 days ago
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Pharmaceutical Quality Assurance Specialist (Remote)
Posted 4 days ago
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Job Description
Key Responsibilities:
- Developing, implementing, and maintaining Quality Management Systems (QMS) in accordance with relevant pharmaceutical regulations.
- Reviewing and approving batch records, manufacturing instructions, and validation protocols.
- Conducting internal audits and supporting external audits by regulatory agencies and clients.
- Investigating deviations, out-of-specification results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
- Monitoring and analyzing quality metrics, identifying trends, and recommending process improvements.
- Ensuring all quality-related documentation is accurate, complete, and compliant.
- Participating in the qualification and validation of equipment and processes.
- Providing training on quality assurance principles and regulatory requirements to relevant personnel.
- Staying current with evolving pharmaceutical regulations and industry best practices.
- Collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance.
Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 4 days ago
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Lead Pharmaceutical Quality Assurance Specialist - Remote
Posted 16 days ago
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The primary responsibilities include developing, implementing, and maintaining robust quality assurance policies and procedures. You will conduct internal audits, supplier audits, and support external regulatory inspections, ensuring readiness and compliance. The Lead QA Specialist will investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing effective corrective and preventive actions (CAPAs). This role involves reviewing and approving critical documentation, such as batch records, validation reports, and change controls. You will also be responsible for training and mentoring junior QA team members, fostering a culture of quality excellence throughout the organization. Collaboration with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, is essential to ensure seamless integration of quality principles. The successful candidate will possess strong leadership capabilities, exceptional analytical and problem-solving skills, and the ability to make sound decisions in complex situations. Excellent written and verbal communication skills are required for reporting, documentation, and stakeholder engagement. This fully remote position offers the flexibility to contribute significantly to the company's quality objectives without the need for daily office presence. We seek a highly motivated professional who is passionate about ensuring the safety, efficacy, and quality of pharmaceutical products. The impact of this role, operating from a virtual capacity with connections to **Ruiru, Kiambu, KE**, is far-reaching across global health standards.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 20 days ago
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Senior Pharmaceutical Quality Assurance Specialist - Remote Compliance Officer
Posted 22 days ago
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Key responsibilities include:
- Developing, implementing, and overseeing pharmaceutical quality assurance programs and policies.
- Conducting internal and external audits of manufacturing facilities, laboratories, and clinical trial sites to ensure compliance with regulatory standards (e.g., FDA, EMA, WHO).
- Reviewing and approving batch records, validation protocols, and other critical quality documentation.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Ensuring that all pharmaceutical products meet predefined quality specifications and regulatory requirements before release.
- Collaborating closely with R&D, manufacturing, regulatory affairs, and clinical teams to ensure quality is integrated throughout the product lifecycle.
- Developing and delivering quality assurance training programs for relevant personnel.
- Managing and maintaining the company's Quality Management System (QMS), including document control, change control, and risk management processes.
- Staying updated on current pharmaceutical regulations, industry trends, and best practices in quality assurance.
- Preparing for and hosting regulatory inspections and customer audits.
- A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Ph.D. is a plus.
- A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and/or quality control.
- In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant global regulatory requirements.
- Proven experience in conducting successful regulatory audits and hosting inspections.
- Strong analytical skills with the ability to interpret complex data and resolve quality issues effectively.
- Excellent project management and organizational skills, with the ability to manage multiple tasks and projects concurrently in a remote setting.
- Outstanding written and verbal communication skills, with the ability to articulate complex quality and regulatory issues clearly.
- Proficiency in quality management software and tools.
- A proactive approach to problem-solving and a commitment to maintaining the highest quality standards.
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Remote Pharmaceutical Quality Assurance Analyst
Posted 22 days ago
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Job Description
Key Responsibilities:
- Review and approve batch records, analytical data, and validation reports.
- Investigate deviations, out-of-specifications (OOS), and customer complaints.
- Develop and implement Corrective and Preventive Actions (CAPAs).
- Ensure compliance with GMP, GLP, and other relevant regulatory guidelines.
- Participate in internal and external audits as a remote representative.
- Contribute to the development and maintenance of Quality Management Systems (QMS).
- Perform risk assessments related to product quality and regulatory compliance.
- Monitor key quality indicators and prepare quality performance reports.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Stay updated on pharmaceutical regulations and quality standards.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Proven experience in Pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of GMP, GLP, and relevant pharmaceutical regulations.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent documentation and technical writing abilities.
- Experience with QMS and CAPA systems.
- Ability to work independently and manage multiple tasks in a remote setting.
- Proficiency with common pharmaceutical industry software and data analysis tools.
- Strong communication and interpersonal skills for remote collaboration.
Remote Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS).
- Ensure compliance with GMP, GLP, and other relevant pharmaceutical regulations.
- Review and approve batch manufacturing records and associated documentation.
- Investigate deviations, OOS results, and customer complaints, implementing CAPA plans.
- Conduct internal audits and support external regulatory inspections.
- Collaborate with R&D, manufacturing, and regulatory affairs teams on quality-related matters.
- Develop and deliver training programs on quality standards and procedures.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Participate in supplier qualification and quality agreements.
- Maintain accurate and organized quality records.
- 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 GMP, GLP, ICH guidelines, and other relevant regulatory standards.
- Experience with QMS, CAPA, deviation management, and change control processes.
- Proficiency in quality management software and statistical analysis tools.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent documentation and communication skills.
- Ability to work independently, manage priorities, and meet deadlines in a remote environment.
- Detail-oriented with a strong commitment to quality and compliance.
Lead Remote Pharmaceutical Quality Assurance Specialist
Posted 7 days ago
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