338 Assurance Specialist jobs in Kenya
Senior Quality Assurance Specialist
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Responsibilities:
- Develop and implement quality assurance programs for cleaning and sanitation services.
- Conduct regular site inspections and audits to ensure compliance with standards.
- Identify and document any deviations from quality and hygiene protocols.
- Develop and implement corrective action plans to address quality issues.
- Ensure compliance with all relevant health, safety, and sanitation regulations.
- Monitor the effectiveness of cleaning processes and procedures.
- Train cleaning staff on quality standards and best practices.
- Maintain detailed records of inspections, audits, and training.
- Collaborate with facility management and cleaning teams to improve service quality.
- Provide regular reports on quality assurance findings and recommendations.
- Bachelor's degree in a related field or equivalent experience.
- Minimum of 5 years of experience in quality assurance, preferably in cleaning or facilities management.
- Strong knowledge of cleaning techniques, sanitation standards, and safety regulations.
- Experience with quality management systems and audit procedures.
- Excellent attention to detail and analytical skills.
- Strong written and verbal communication skills.
- Ability to develop and deliver training programs.
- Proficiency in using quality management software is a plus.
- Ability to work independently and manage time effectively in a remote environment.
- Problem-solving skills and a proactive approach to quality improvement.
Lead Quality Assurance Specialist
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Pharmaceutical Quality Assurance Specialist
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Key Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS) in accordance with cGMP, ICH, and other relevant guidelines.
- Conduct internal and external audits of manufacturing facilities, suppliers, and processes.
- 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).
- Ensure compliance with regulatory requirements from agencies such as the FDA, EMA, and local health authorities.
- Participate in regulatory inspections and provide necessary support.
- Develop and deliver quality training programs to relevant personnel.
- Manage change control processes and assess the impact of changes on product quality.
- Monitor key quality metrics and provide reports on quality performance.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs.
- Stay current with evolving regulatory landscapes and industry best practices.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Experience with quality management systems, audits, and regulatory submissions.
- Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in documentation review and report writing.
- Exceptional attention to detail and accuracy.
- Strong communication and interpersonal skills, enabling effective collaboration in a remote team.
- Familiarity with CAPA systems and change control procedures.
Pharmaceutical Quality Assurance Specialist
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Pharmaceutical Quality Assurance Specialist
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Job Description
Key duties include conducting internal audits to assess compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations. You will also participate in external audits by regulatory agencies and clients, preparing necessary documentation and responding to inquiries. This position involves close collaboration with R&D, production, and regulatory affairs departments to identify and mitigate quality risks. The ideal candidate will possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline, along with a minimum of 3 years of experience in pharmaceutical quality assurance. A thorough understanding of ICH guidelines and pharmaceutical manufacturing processes is essential. Strong analytical, problem-solving, and documentation skills are paramount. Excellent communication and interpersonal abilities are required to effectively interact with cross-functional teams and external partners. This role offers a hybrid work arrangement, providing a balance between remote work flexibility and in-person collaboration required for specific quality control activities and team meetings at our Nyeri facility.
Pharmaceutical Quality Assurance Specialist
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Key Responsibilities:
- Develop, implement, and maintain quality assurance systems and procedures in compliance with cGMP and other relevant regulations.
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Participate in process validation and equipment qualification activities.
- Monitor and analyze quality metrics, identifying trends and recommending improvements.
- Ensure that all manufacturing and testing processes adhere to established quality standards.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Maintain the Document Control system and ensure all SOPs are current and followed.
- Train personnel on quality assurance principles and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- A minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant regulatory requirements.
- Experience with quality management systems (QMS), including deviation management and CAPA.
- Familiarity with validation processes (IQ/OQ/PQ) and regulatory submissions.
- Strong analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple tasks and prioritize effectively.
- Proficiency in Microsoft Office Suite and experience with electronic QMS is preferred.
- Comfortable working in a hybrid environment, balancing remote and on-site responsibilities.
Pharmaceutical Quality Assurance Specialist
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Key Responsibilities:
- Develop, implement, and maintain Quality Assurance systems and procedures.
- Review and approve batch records, specifications, and other critical quality documents.
- Conduct internal audits of manufacturing processes, laboratories, and documentation.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints.
- Develop and manage Corrective and Preventive Actions (CAPA) plans.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Participate in regulatory inspections and audits from health authorities.
- Train personnel on quality systems and compliance requirements.
- Contribute to the continuous improvement of quality processes and systems.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- Thorough understanding of GMP, GLP, and other pharmaceutical regulatory requirements.
- Experience with deviation management, CAPA, and change control systems.
- Proficiency in reviewing batch records and analytical data.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills.
- Ability to work independently and manage responsibilities effectively in a remote setting.
- Detail-oriented with strong organizational skills.
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Pharmaceutical Quality Assurance Specialist
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Key responsibilities:
- Develop, implement, and maintain quality assurance policies and procedures.
- Conduct internal audits of manufacturing processes, documentation, and facilities to ensure GMP compliance.
- Review and approve batch production records, analytical test results, and other quality-related documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing CAPAs.
- Manage the CAPA system, ensuring timely and effective closure of corrective and preventive actions.
- Participate in external audits and regulatory inspections.
- Provide training to personnel on quality systems, GMP, and relevant regulatory requirements.
- Monitor key quality metrics and generate reports for management review.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Collaborate with cross-functional teams to ensure product quality and compliance.
Pharmaceutical Quality Assurance Specialist
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Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Ensure compliance with all relevant pharmaceutical regulations and guidelines (e.g., GMP, ISO).
- Conduct internal audits of manufacturing processes, facilities, and documentation.
- Review and approve batch manufacturing records, ensuring accuracy and completeness.
- Manage deviations, out-of-specification (OOS) results, and implement Corrective and Preventive Actions (CAPAs).
- Participate in external audits conducted by regulatory authorities and customers.
- Validate manufacturing processes, equipment, and analytical methods.
- Ensure proper calibration and maintenance of laboratory and production equipment.
- Train personnel on quality standards, GMP, and other relevant procedures.
- Collaborate with production, R&D, and other departments to resolve quality issues.
- Maintain up-to-date knowledge of pharmaceutical regulations and industry best practices.
- Prepare quality reports and contribute to continuous improvement initiatives.
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of Good Manufacturing Practices (GMP) and pharmaceutical quality systems.
- Experience with regulatory compliance, audits, and documentation.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent attention to detail and organizational abilities.
- Proficiency in Microsoft Office Suite and quality management software.
- Ability to work effectively in a team and communicate clearly with cross-functional departments.
- Understanding of validation processes (Process, Cleaning, Equipment) is a plus.
Pharmaceutical Quality Assurance Specialist
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- Developing and implementing quality assurance procedures and protocols.
- Conducting internal audits to ensure compliance with GMP (Good Manufacturing Practices) and other relevant standards.
- Reviewing and approving documentation, including batch records, validation reports, and SOPs.
- Investigating deviations, CAPAs (Corrective and Preventive Actions), and out-of-specification results.
- Managing product complaints and ensuring timely resolution.
- Preparing for and participating in regulatory inspections.
- Collaborating with R&D, manufacturing, and regulatory affairs departments.
- Maintaining quality records and ensuring data integrity.
- Providing training to staff on quality-related matters.
- Staying updated on regulatory changes and industry best practices.
The ideal candidate must possess a Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field. A minimum of 4 years of experience in pharmaceutical quality assurance or quality control is required. Familiarity with regulatory guidelines (e.g., ICH, FDA) and experience with quality management systems are essential. Strong analytical, documentation, and communication skills are a must. This role requires a meticulous and organized individual who can work effectively in a remote environment, ensuring the consistent quality and compliance of pharmaceutical products.