What Jobs are available for Quality Assurance Specialist in Kenya?

Role Description

This is a full-time on-site role for a Quality Assurance Specialist located in Nakuru, Kenya. The Quality Assurance Specialist will be responsible for implementing and managing quality assurance processes, conducting quality audits, ensuring adherence to Good Manufacturing Practice (GMP), and overseeing quality management systems. The role involves day-to-day tasks such as monitoring quality control procedures, preparing quality reports, and collaborating with other departments to maintain high quality standards.

Qualifications

• Experience in Quality Control and Quality Assurance
• Knowledge of Quality Management Systems and Good Manufacturing Practice (GMP)
• Proficiency in conducting Quality Audits
• Strong attention to detail and analytical skills
• Excellent communication and teamwork abilities
• Bachelor's degree in a related field such as Quality Management, Engineering, or a scientific discipline
• Prior experience in a quality assurance role is preferred

Role Description

This is a full-time hybrid role for a Quality Assurance Specialist located in Thika, with some work from home acceptable. The Quality Assurance Specialist will be responsible for performing quality control tests, maintaining quality management systems, ensuring compliance with Good Manufacturing Practices (GMP), and carrying out quality audits. They will analyze data to identify areas for improvement and ensure that all products meet the highest standards of quality and safety.

Qualifications

• Quality Control and Quality Assurance skills
• Experience in Quality Management.
• Knowledge of Quality Auditing
• Excellent attention to detail and problem-solving skills
• Strong analytical and communication skills
• Ability to work independently and as part of a team
• Bachelor's degree in a related field or equivalent experience
• Experience in the digital consultancy industry is a plus

• Develop, implement, and maintain the Quality Management System (QMS).
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Conduct internal audits of manufacturing processes, facilities, and documentation.
• Review and approve batch records, validation protocols, and reports.
• Investigate deviations, non-conformances, and customer complaints.
• Develop and implement Corrective and Preventive Actions (CAPAs).
• Participate in external audits by regulatory agencies and customers.
• Manage and maintain quality-related documentation and records.
• Provide training to personnel on quality assurance procedures and GMP principles.
• Collaborate with production, R&D, and other departments to resolve quality issues.
• Stay updated on changes in pharmaceutical regulations and quality standards.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP, ISO standards, and pharmaceutical regulatory requirements.
• Experience with quality control testing, batch record review, and deviation management.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent attention to detail and organizational abilities.
• Proficiency in Microsoft Office Suite and quality management software.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a collaborative team.
• Pharmaceutical industry certifications are a plus.

• 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.

• Develop and implement comprehensive quality assurance policies and procedures for cleaning and sanitation operations.
• Conduct regular site inspections and audits to ensure compliance with established standards and regulatory requirements.
• Train and supervise cleaning staff on proper cleaning techniques, product usage, and safety protocols.
• Investigate and resolve sanitation issues and customer complaints promptly.
• Maintain detailed records of inspections, training, and corrective actions.
• Source and evaluate cleaning supplies and equipment for quality and cost-effectiveness.
• Stay updated on industry trends, new technologies, and best practices in cleaning and sanitation.
• Collaborate with management to set quality objectives and key performance indicators (KPIs).
• Ensure a safe and healthy working environment for all staff.
• Prepare reports on quality assurance findings and recommendations for improvement.

• Proven experience in a quality assurance or management role within the cleaning and sanitation industry.
• In-depth knowledge of sanitation principles, health regulations, and safety standards (e.g., HACCP).
• Excellent leadership, communication, and interpersonal skills.
• Ability to train and motivate teams effectively, particularly in a remote setting.
• Strong analytical and problem-solving abilities.
• Proficiency in using quality management software and tools.
• Detail-oriented with a commitment to excellence.
• High school diploma or equivalent; certification in a relevant field is a plus.

• Develop and implement comprehensive quality assurance protocols for cleaning and sanitation services.
• Conduct regular on-site inspections of facilities to assess adherence to quality standards and hygiene protocols.
• Train cleaning staff on proper techniques, safety procedures, and the use of cleaning equipment and chemicals.
• Develop and deliver training materials and modules.
• Investigate and resolve quality-related complaints or issues promptly and effectively.
• Monitor and analyze cleaning performance data, identifying trends and areas for improvement.
• Ensure compliance with all health, safety, and environmental regulations.
• Maintain detailed records of inspections, training, and quality control activities.
• Recommend and implement process improvements to enhance service delivery and efficiency.
• Collaborate with operations teams to ensure seamless integration of quality standards.

• Developing and implementing comprehensive quality assurance programs for cleaning and sanitation services.
• Conducting remote audits and inspections of cleaning procedures and outcomes.
• Analyzing inspection data to identify trends, non-compliance issues, and areas for improvement.
• Ensuring adherence to established cleaning protocols, safety standards, and regulatory requirements.
• Developing training materials and conducting remote training sessions for cleaning staff on quality standards.
• Monitoring the effectiveness of cleaning products and equipment, recommending updates as needed.
• Investigating and resolving quality-related complaints or issues.
• Preparing detailed reports on quality assurance findings and recommendations for management.
• Staying updated on industry best practices and emerging trends in cleaning and sanitation.
• Collaborating with operational teams to ensure the consistent application of quality standards.
• Maintaining accurate records of all quality assurance activities.
• Driving continuous improvement initiatives to enhance the overall quality of services.

• 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.

• 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.