6,668 Lead Pharmaceutical Quality Assurance Manager jobs in Kenya
Lead Pharmaceutical Quality Assurance Manager
Posted 21 days ago
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Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in line with global regulatory standards (e.g., GMP, ISO).
- Lead and mentor a team of Quality Assurance professionals in a remote setting.
- Oversee and conduct internal and external audits of manufacturing facilities, suppliers, and processes.
- Manage deviation investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Manage product release processes to ensure products meet all quality and regulatory requirements.
- Develop and deliver quality training programs for staff.
- Act as a key point of contact for regulatory inspections and agency interactions.
- Drive continuous improvement initiatives within the QA department and across the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance, with at least 2 years in a leadership role.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in auditing, CAPA management, and QMS implementation.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and interpersonal skills.
- Proficiency in quality management software and tools.
- Ability to manage projects and teams effectively in a remote environment.
Lead Pharmaceutical Quality Assurance Manager (Remote)
Posted 21 days ago
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Job Description
Responsibilities:
- Lead the development, implementation, and maintenance of the Pharmaceutical Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP) and relevant international regulatory standards (e.g., ICH).
- Oversee SOP development, implementation, and training.
- Manage change control, deviation, and CAPA (Corrective and Preventive Actions) systems.
- Conduct internal audits and support external regulatory inspections.
- Review and approve validation master plans, protocols, and reports.
- Assess and manage quality-related risks throughout the product lifecycle.
- Mentor and guide a team of Quality Assurance professionals.
- Collaborate with R&D, manufacturing, and regulatory affairs to ensure quality standards are met.
- Promote a culture of quality and continuous improvement within the organization.
- Ensure data integrity across all quality-related systems and processes.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Master's degree is a plus.
- Minimum of 7 years of experience in Pharmaceutical Quality Assurance, with at least 2 years in a lead or managerial role.
- In-depth knowledge of GMP regulations and quality system principles.
- Experience with QMS software, validation, audits, and regulatory submissions.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal skills.
- Proven ability to manage multiple projects and priorities in a remote setting.
Lead Pharmaceutical Quality Assurance Manager - Regulatory Compliance
Posted 21 days ago
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Job Description
Key Responsibilities:
- Establish, maintain, and continuously improve the company's Quality Management System (QMS) in alignment with cGMP, FDA, EMA, and other relevant global regulatory requirements.
- Lead and mentor a team of Quality Assurance professionals, fostering a culture of quality excellence and continuous improvement.
- Oversee all quality-related activities, including batch record review, release processes, deviation management, CAPA implementation, and change control.
- Develop and manage validation strategies for manufacturing processes, analytical methods, and equipment.
- Conduct internal audits and host regulatory inspections, ensuring preparedness and successful outcomes.
- Collaborate closely with R&D, Manufacturing, and Regulatory Affairs departments to ensure seamless product development and commercialization.
- Monitor and analyze quality metrics, identifying trends and implementing corrective actions to mitigate risks.
- Stay current with evolving regulatory guidelines and best practices in the pharmaceutical industry and implement necessary updates to policies and procedures.
- Manage vendor qualification and audit programs to ensure the quality of supplied materials and services.
- Develop and deliver comprehensive training programs on quality and compliance topics to relevant personnel.
Lead Quality Assurance Manager - Manufacturing
Posted 5 days ago
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Lead Remote Pharmaceutical Quality Assurance Manager
Posted 10 days ago
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Process Improvement Engineer - Manufacturing
Posted 20 days ago
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Job Description
Responsibilities:
- Analyze existing manufacturing processes to identify inefficiencies, bottlenecks, and areas for improvement.
- Develop and implement data-driven strategies for process optimization using Lean Manufacturing, Six Sigma, and other methodologies.
- Design and conduct experiments to test new process parameters and technologies.
- Create detailed process documentation, including standard operating procedures (SOPs) and flowcharts.
- Collaborate with production teams, quality control, and management to implement changes and ensure successful adoption.
- Monitor key performance indicators (KPIs) related to production efficiency, quality, and cost.
- Lead and participate in continuous improvement projects, from conception to completion.
- Train production staff on new processes and best practices.
- Utilize statistical software and tools for data analysis and reporting.
- Stay current with advancements in industrial engineering and manufacturing technologies.
Qualifications:
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
- Proven experience (3+ years) in process improvement within a manufacturing environment.
- Strong understanding of Lean Manufacturing principles and Six Sigma methodologies (Green Belt or Black Belt certification is a plus).
- Proficiency in process mapping, value stream mapping, and root cause analysis techniques.
- Experience with statistical analysis software (e.g., Minitab, R) and data visualization tools.
- Excellent problem-solving skills and a methodical approach to identifying solutions.
- Strong project management abilities, with the capacity to manage multiple initiatives simultaneously.
- Effective communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
- Ability to work collaboratively in a hybrid environment, balancing remote work with on-site presence for critical tasks and team meetings.
- Knowledge of CAD software is an advantage.
The successful candidate will play a crucial role in driving operational excellence and maintaining our competitive edge. This role requires a strategic thinker with a hands-on approach to problem-solving and a commitment to continuous improvement. We are looking for an individual who can analyze complex systems and implement effective, sustainable solutions within our manufacturing operations located in Nakuru.
Process Improvement Industrial Engineer
Posted 17 days ago
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Job Description
Key Responsibilities:
- Analyze existing manufacturing and operational processes to identify areas for improvement in efficiency, quality, and cost-effectiveness.
- Design, develop, and implement new processes and systems using principles of industrial engineering, lean manufacturing, and Six Sigma.
- Collect and interpret data related to production, workflow, and resource utilization.
- Develop and maintain process documentation, including standard operating procedures (SOPs) and work instructions.
- Conduct time and motion studies to optimize workforce efficiency and ergonomic design.
- Utilize simulation software to model and test process changes before implementation.
- Train and mentor operational staff on new processes and best practices.
- Prepare detailed reports and present findings and recommendations to management.
- Collaborate with cross-functional teams, including production, quality assurance, and supply chain, to ensure seamless integration of improvements.
- Monitor the performance of implemented solutions and make adjustments as needed.
Required Qualifications:
- Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or a related field.
- Minimum of 5 years of experience in process improvement, lean manufacturing, or operations management within an industrial setting.
- Proven experience with lean manufacturing principles, Six Sigma methodologies (Green Belt or Black Belt certification preferred).
- Proficiency in data analysis tools and techniques, including statistical software (e.g., Minitab) and Microsoft Excel.
- Experience with process mapping and simulation software is a strong asset.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Strong communication and presentation skills, with the ability to influence stakeholders at all levels.
- Ability to work independently and as part of a team.
- Familiarity with supply chain and logistics operations is beneficial.
- Must be legally authorized to work in Kenya.
This role offers a competitive salary and benefits package, along with significant opportunities for professional growth within a growing organization. Join us in shaping the future of our operations.
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Process Improvement Engineer - Manufacturing Excellence
Posted 21 days ago
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Key responsibilities include conducting detailed process analyses, utilizing methodologies such as Lean Manufacturing, Six Sigma, and Kaizen. You will map existing workflows, identify root causes of issues, and develop innovative solutions to streamline operations. This may involve re-engineering production lines, optimizing material flow, implementing new technologies, or improving quality control measures. You will collaborate closely with production teams, engineering departments, and management to ensure the successful implementation and sustainability of improvement initiatives. Developing and presenting business cases for proposed changes, tracking key performance indicators (KPIs), and ensuring projects are completed on time and within budget will be essential. A strong understanding of industrial engineering principles, statistical process control (SPC), and various manufacturing systems is required.
This role is fully remote, allowing you to contribute your process improvement expertise to optimize operations across our various facilities without the need for on-site presence. We are seeking a highly analytical, results-driven individual with exceptional problem-solving skills and a passion for operational efficiency. Strong project management and communication skills are vital for coordinating with diverse stakeholders. A Bachelor's or Master's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field is required. Relevant certifications such as Lean Six Sigma Black Belt or Green Belt are highly desirable. A minimum of 6 years of progressive experience in process improvement within a manufacturing environment is necessary.
Remote Process Improvement Engineer (Manufacturing)
Posted 21 days ago
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Job Description
Key Responsibilities:
- Analyze existing manufacturing processes to identify bottlenecks, waste, and areas for improvement.
- Develop and implement data-driven strategies for process optimization, cost reduction, and quality enhancement.
- Apply lean manufacturing principles (e.g., 5S, Kaizen, Value Stream Mapping) and Six Sigma methodologies to improve operational efficiency.
- Design and execute experiments to test new process designs and validate improvements.
- Develop standard operating procedures (SOPs) and best practices for various manufacturing activities.
- Collaborate with cross-functional teams, including production, quality assurance, and engineering, to implement changes.
- Monitor the performance of implemented improvements and provide ongoing support.
- Utilize simulation software and data analysis tools to model and predict process outcomes.
- Prepare detailed reports and presentations on findings, recommendations, and project progress.
- Stay current with advancements in manufacturing technology and process improvement techniques.
Qualifications:
- Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.
- Minimum of 5 years of experience in process improvement, lean manufacturing, or operations management within a manufacturing environment.
- Certified Lean Six Sigma Green Belt or Black Belt is highly desirable.
- Proficiency in process mapping tools (e.g., Visio) and data analysis software (e.g., Minitab, Excel).
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent project management and organizational abilities.
- Effective communication and interpersonal skills to collaborate with remote teams.
- Experience in a remote work setting is a plus.
- Knowledge of various manufacturing processes and equipment.
This role is based out of Kericho, Kericho, KE and is a fully remote position, offering a fantastic opportunity to shape manufacturing excellence from a distance.
Senior Process Improvement Engineer (Manufacturing)
Posted 11 days ago
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Job Description
Key Responsibilities:
- Lead the analysis and redesign of manufacturing processes to improve throughput, reduce waste, and increase efficiency.
- Develop and implement Lean and Six Sigma methodologies across various production lines.
- Utilize process mapping, root cause analysis, and statistical tools to identify areas for improvement.
- Design and conduct experiments (DOE) to validate process changes and optimize parameters.
- Develop and implement KPIs and control plans to monitor process performance and ensure sustained improvements.
- Collaborate with plant managers and production staff to implement process changes and provide training.
- Create detailed documentation for new and revised processes, including standard operating procedures (SOPs).
- Work with automation and engineering teams to integrate new technologies for process enhancement.
- Manage projects related to process improvement, ensuring they are completed on time and within budget.
- Stay abreast of industry best practices and emerging technologies in manufacturing and process optimization.
- Effectively communicate findings, recommendations, and project updates to stakeholders through virtual channels.
Qualifications:
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field. A Master's degree is a plus.
- Minimum of 6-8 years of progressive experience in process improvement, manufacturing engineering, or operations management.
- Proven expertise in Lean Manufacturing principles and Six Sigma methodologies (Green Belt or Black Belt certification highly preferred).
- Strong analytical and statistical skills, with proficiency in statistical software (e.g., Minitab).
- Experience with process simulation software is an advantage.
- Excellent project management and organizational skills.
- Strong problem-solving abilities and a data-driven approach.
- Exceptional communication and interpersonal skills, vital for remote collaboration and influencing.
- Ability to work independently and drive results in a remote setting.
- Experience with manufacturing execution systems (MES) is a plus.
- Familiarity with quality management systems (e.g., ISO 9001).
This fully remote position offers an exciting opportunity to drive significant improvements in manufacturing operations globally. If you are a results-oriented engineer passionate about optimizing processes, we encourage you to apply.