Remote Sanitation Quality Assurance Specialist
Posted 19 days ago
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Senior Cleaning & Sanitation Quality Assurance Specialist - Remote
Posted 2 days ago
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- Developing and implementing cleaning and sanitation quality assurance programs.
- Conducting regular inspections and audits of cleaning services.
- Developing and delivering training programs for cleaning staff on best practices.
- Ensuring compliance with health, safety, and hygiene regulations.
- Analyzing quality control data and identifying areas for improvement.
- Developing corrective action plans and monitoring their implementation.
- Researching and recommending new cleaning technologies and products.
- Preparing detailed reports on quality assurance findings and recommendations.
- Collaborating with site managers and cleaning supervisors to ensure consistent service delivery.
Lead Pharmaceutical Quality Assurance Specialist
Posted 6 days ago
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Senior Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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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.
Remote Pharmaceutical Quality Assurance Specialist
Posted 22 days ago
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Responsibilities:
- Develop, implement, and maintain quality management systems and procedures.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Conduct internal audits and participate in external audits of suppliers and partners.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints.
- Develop and implement corrective and preventive actions (CAPA) to address quality issues.
- Ensure compliance with relevant regulatory requirements (e.g., FDA, EMA, local health authorities).
- Train personnel on quality assurance policies and procedures.
- Monitor and analyze quality metrics and trends, reporting findings to management.
- Participate in process validation and qualification activities.
- Manage the change control process effectively.
- Stay updated on regulatory changes and industry best practices in pharmaceutical quality assurance.
- Contribute to the continuous improvement of quality systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GLP, and other relevant quality standards.
- Familiarity with regulatory submission processes and requirements.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and investigative skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, adapted for remote collaboration.
- Ability to work independently, prioritize tasks, and manage time effectively in a remote environment.
- Proficiency in quality management software and MS Office Suite.
Principal Pharmaceutical Quality Assurance Engineer
Posted 7 days ago
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- Lead and manage all aspects of the Quality Assurance (QA) function for pharmaceutical products, ensuring compliance with global regulatory standards (FDA, EMA, etc.).
- Develop, implement, and maintain the company's Quality Management System (QMS), including SOPs, batch records, and validation protocols.
- Oversee the quality control of raw materials, in-process testing, and finished product release.
- Conduct internal audits and host regulatory inspections, ensuring readiness and compliance.
- Investigate deviations, non-conformances, and CAPA (Corrective and Preventive Actions), implementing effective solutions to prevent recurrence.
- Review and approve manufacturing process validation, equipment qualification, and cleaning validation reports.
- Manage change control processes and ensure all changes are properly assessed, documented, and implemented.
- Provide QA oversight for product development, technology transfer, and commercial manufacturing activities.
- Train and mentor QA team members and other personnel on quality systems and regulatory requirements.
- Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure integrated quality approaches.
- Stay current with evolving regulatory expectations and industry best practices in pharmaceutical quality assurance.
- Contribute to strategic quality initiatives and continuous improvement programs.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of GMP, GLP, ICH guidelines, and regulatory submission requirements.
- Proven experience in developing, implementing, and managing robust QMS.
- Strong background in validation (process, equipment, cleaning) and batch record review.
- Demonstrated experience in managing deviations, CAPAs, and change controls.
- Excellent leadership, communication, and interpersonal skills, with the ability to influence and drive compliance.
- Experience with sterile manufacturing and aseptic processing is highly advantageous.
- Proficiency in quality risk management principles.
- Ability to work autonomously, manage complex projects, and lead remote teams effectively.
- Familiarity with pharmaceutical manufacturing processes and analytical testing methods.
Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 12 days ago
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Key Responsibilities Include:
- Developing, implementing, and maintaining quality assurance systems and procedures in accordance with cGMP, ICH guidelines, and other relevant regulations.
- Reviewing and approving manufacturing batch records, analytical data, and validation protocols.
- Conducting internal audits and participating in external regulatory inspections.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
- Managing change control processes and ensuring all changes are properly assessed and documented.
- Preparing and submitting quality-related documentation for regulatory filings.
- Training QA/QC personnel and other relevant staff on quality systems and compliance.
- Monitoring and assessing supplier quality performance.
- Staying current with evolving pharmaceutical regulations and industry best practices.
- Contributing to the continuous improvement of the Quality Management System (QMS).
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus. A minimum of 5-7 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry is mandatory. Thorough knowledge of cGMP, regulatory requirements (e.g., FDA, EMA), and quality risk management principles is essential. Excellent analytical, problem-solving, and documentation skills are required. Strong written and verbal communication skills are paramount. As this is a fully remote role, a high degree of self-motivation, attention to detail, and the ability to work independently with minimal supervision are crucial. This role supports quality operations relevant to the Mombasa, Mombasa, KE region.
This is an excellent opportunity for a seasoned QA professional to contribute to critical quality functions in a dynamic and flexible remote work environment. If you are dedicated to ensuring pharmaceutical product quality and compliance, we encourage you to apply.
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Remote Senior Pharmaceutical Quality Assurance Specialist
Posted 22 days ago
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Key Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH guidelines).
- Oversee and participate in internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
- Review and approve critical quality documents, including batch records, validation protocols, SOPs, and change controls.
- Lead and participate in investigations of deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results.
- Assess and manage quality risks associated with product development, manufacturing, and supply chain.
- Provide training and guidance to internal teams and external partners on quality assurance principles and regulatory requirements.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Collaborate with regulatory affairs to ensure compliance with all applicable regulations.
- Contribute to the development and continuous improvement of quality policies and procedures.
- Stay current with evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
- Manage quality aspects of product lifecycle, from development through post-market surveillance.
- 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 and Quality Control.
- Extensive knowledge of GMP, GLP, GCP, and other relevant pharmaceutical quality systems and regulations.
- Proven experience in conducting and managing audits, investigations, and risk assessments.
- Strong understanding of pharmaceutical manufacturing processes and product development.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to communicate complex technical and regulatory information clearly.
- Ability to work independently, manage multiple projects, and prioritize effectively in a remote setting.
- Proficiency in quality management software and standard office applications.
Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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Lead Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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Responsibilities:
- Lead and manage the Quality Assurance department, ensuring compliance with all relevant pharmaceutical regulations and standards.
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Oversee all aspects of batch record review, product release, and stability testing programs.
- Conduct internal audits and host regulatory inspections, ensuring all findings are addressed promptly.
- Investigate deviations, customer complaints, and product quality issues, implementing effective CAPAs.
- Manage the change control process and ensure that all changes are assessed for their impact on product quality.
- Provide training and mentorship to QA staff.
- Collaborate with R&D, manufacturing, and regulatory affairs to ensure product quality throughout its lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices.
- Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance.
- Extensive knowledge of cGMP, GDP, and ICH guidelines.
- Proven experience in managing regulatory inspections and audits (e.g., FDA, EMA).
- Strong leadership, team management, and interpersonal skills.
- Excellent analytical, problem-solving, and decision-making abilities.
- Proficiency in quality risk management principles.
- Exceptional written and verbal communication skills.