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Lead Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Key responsibilities include developing, implementing, and maintaining quality assurance programs and procedures. You will conduct internal audits, review batch records, manage deviations and change controls, and participate in regulatory inspections. The role involves collaborating with various departments, including R&D, manufacturing, and quality control, to ensure seamless integration of quality into all processes. Experience in quality risk management and CAPA (Corrective and Preventive Actions) implementation is essential. You will play a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. This position demands exceptional analytical skills, strong problem-solving capabilities, and a commitment to continuous improvement. The ability to interpret complex regulations and apply them effectively in a practical setting is paramount. You will contribute significantly to maintaining our client's reputation for excellence and compliance. This is a key role located within our facilities at Kitale, Trans-Nzoia, KE .
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal audits and inspections to ensure compliance with GMP and regulatory standards.
- Review and approve batch records, specifications, and validation documents.
- Manage deviations, out-of-specification (OOS) results, and change control processes.
- Participate in external audits and inspections by regulatory authorities.
- Collaborate with manufacturing, R&D, and QC departments to resolve quality issues.
- Implement CAPA (Corrective and Preventive Actions) to address quality deficiencies.
- Stay up-to-date with relevant pharmaceutical regulations and industry best practices.
- Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
- 3+ years of experience in pharmaceutical quality assurance or quality control.
- Thorough understanding of GMP, ISO standards, and regulatory requirements (e.g., FDA, EMA).
- Experience with QMS, audits, deviation management, and CAPA.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
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Principal Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Key Responsibilities:
- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Oversee and manage quality assurance activities, including batch record review, deviation investigation, CAPA management, and change control.
- Conduct internal and external audits (supplier audits) to ensure compliance with regulatory standards and company policies.
- Develop and implement validation strategies for manufacturing processes, equipment, and analytical methods.
- Prepare and review regulatory submission documents related to quality aspects.
- Lead and participate in regulatory inspections by health authorities, ensuring successful outcomes.
- Develop and deliver training programs on quality assurance principles and regulatory compliance for relevant personnel.
- Identify quality risks and implement effective risk mitigation strategies throughout the product lifecycle.
- Analyze quality data to identify trends, root causes of deviations, and areas for improvement.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless integration of quality considerations into all project phases.
Qualifications:
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in pharmaceutical quality assurance and quality control, with at least 5 years in a leadership or principal specialist role.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements in major markets (US, EU, etc.).
- Proven experience in developing and managing comprehensive QMS, including OOS investigations, CAPA, and change control.
- Strong experience with audits (internal, external, regulatory) and regulatory submissions.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to effectively present complex information to diverse audiences.
- Demonstrated ability to lead teams and drive quality initiatives in a remote setting.
- Proficiency in using quality management software and data analysis tools.
- Strong understanding of pharmaceutical manufacturing processes and technologies.
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Pharmaceutical Quality Assurance Specialist
Posted 5 days ago
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Responsibilities:
- Develop and maintain the Quality Management System (QMS), including SOPs and work instructions.
- Conduct batch record reviews and ensure compliance with regulatory requirements.
- Investigate deviations, customer complaints, and Out-of-Specification (OOS) results.
- Implement and manage Corrective and Preventive Actions (CAPA).
- Perform internal audits and support external audits by regulatory agencies.
- Evaluate and qualify suppliers to ensure quality standards are met.
- Monitor and analyze quality metrics and trends to identify areas for improvement.
- Ensure compliance with GMP, GDP, and other relevant pharmaceutical regulations.
- Provide training to personnel on quality standards and procedures.
- Stay updated on regulatory changes and industry best practices.
- Bachelor'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, ICH guidelines, and pharmaceutical regulatory requirements.
- Proven experience in QMS implementation, SOP development, and batch record review.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in quality investigation techniques and CAPA management.
- Strong written and verbal communication skills for documentation and interdepartmental collaboration.
- Ability to work independently and manage multiple projects in a remote setting.
- Attention to detail and a commitment to maintaining high-quality standards.
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Senior Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Key responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with global regulatory standards.
- Conduct internal audits and inspections of manufacturing sites, laboratories, and processes to ensure compliance.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality is integrated throughout product development and lifecycle management.
- Investigate product complaints and quality incidents, identifying root causes and implementing effective solutions.
- Prepare for and support external regulatory inspections and audits by health authorities.
- Contribute to the development and delivery of quality training programs for personnel.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Provide expert guidance and support to cross-functional teams on quality-related matters.
- Evaluate and qualify raw material suppliers and contract manufacturing organizations.
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A minimum of 7 years of progressive experience in pharmaceutical quality assurance and quality control is required, with a deep understanding of GMP regulations. Proven experience in auditing, QMS implementation, and regulatory compliance is essential. Excellent analytical, problem-solving, and decision-making skills are necessary, as are strong written and verbal communication abilities. The ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a remote environment is crucial. Experience with electronic QMS platforms is a plus. This is a significant opportunity to shape quality strategies within a growing pharmaceutical organization, contributing directly to patient safety and product excellence. The role is based remotely within the general operational area of Ongata Rongai, Kajiado, KE .
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Pharmaceutical Quality Assurance Specialist (Remote)
Posted 2 days ago
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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.
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Lead Pharmaceutical Quality Assurance Specialist (Remote)
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Lead Remote Pharmaceutical Quality Assurance Specialist
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Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 2 days ago
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