6,560 Senior Pharmaceutical Quality Assurance Manager Remote Compliance jobs in Kenya
Senior Pharmaceutical Quality Assurance Manager - Remote Compliance
Posted 22 days ago
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Job Description
Key responsibilities include overseeing the quality assurance and quality control functions, ensuring product integrity and patient safety. You will lead internal and external audits, manage deviations, change controls, and CAPA systems. This role involves developing and delivering quality training programs to staff and ensuring adherence to established SOPs. You will also be responsible for reviewing and approving batch records, validation protocols, and other critical quality documents. Staying current with evolving global pharmaceutical regulations and ensuring the company remains compliant will be a core function. Collaboration with R&D, manufacturing, and regulatory affairs departments to address quality issues and implement corrective actions is essential.
Candidates must possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred. A minimum of 8-10 years of progressive experience in Quality Assurance/Quality Control within the pharmaceutical industry is required. Demonstrated experience in developing and implementing QMS, leading audits, and managing regulatory inspections is essential. Strong knowledge of GMP, GLP, GDP, and relevant international regulatory guidelines (e.g., FDA, EMA) is a must. Excellent analytical, problem-solving, and decision-making skills are expected. Outstanding communication, leadership, and interpersonal skills are necessary for managing teams remotely and interacting effectively with regulatory bodies and internal stakeholders. The ability to interpret complex regulatory requirements and translate them into actionable quality procedures is crucial.
This is an exceptional opportunity for a seasoned quality professional to drive compliance and ensure excellence in pharmaceutical manufacturing remotely, supporting the company's operations and market presence, including in **Machakos, Machakos, KE**.
Senior Pharmaceutical Quality Assurance Manager - Remote Compliance Lead
Posted 12 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with global pharmaceutical regulations (e.g., GMP, ICH).
- Oversee and manage all aspects of pharmaceutical quality assurance, including batch record review, deviation management, CAPA, and change control.
- Conduct internal audits and support external regulatory inspections (e.g., FDA, EMA).
- Ensure the quality and integrity of raw materials, in-process materials, and finished products.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality throughout the lifecycle.
- Manage vendor quality assessments and ensure supplier compliance.
- Develop and deliver training programs on GMP and quality standards for relevant personnel.
- Investigate product quality complaints and implement corrective and preventive actions.
- Stay abreast of evolving regulatory landscapes and industry best practices.
- Lead and mentor a remote quality assurance team, fostering a culture of quality excellence.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A Master's degree or PhD is a plus.
- Minimum of 8 years of experience in the pharmaceutical industry, with at least 5 years in Quality Assurance/Quality Control roles.
- Extensive knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Proven experience in managing QMS, conducting audits, and handling regulatory inspections.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent communication, leadership, and interpersonal skills, with the ability to effectively manage remote teams.
- Experience with pharmaceutical manufacturing processes and technologies.
- Familiarity with data integrity principles and electronic record-keeping systems.
- Ability to interpret and apply complex regulatory requirements.
- Relevant professional certifications (e.g., ASQ Certified Quality Auditor/Manager) are highly desirable.
Senior Pharmaceutical Quality Assurance Manager - Remote Compliance Expert
Posted 7 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with GMP, ICH, and other relevant regulatory guidelines.
- Oversee and manage all aspects of pharmaceutical quality assurance, including batch record review, deviation investigations, and CAPA management.
- Plan, conduct, and coordinate internal and external audits (vendor qualification, regulatory inspections).
- Ensure compliance with all applicable national and international pharmaceutical regulations.
- Develop and deliver training programs on quality assurance principles and regulatory requirements.
- Lead and manage quality risk assessments and implement mitigation strategies.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Contribute to the development and implementation of new pharmaceutical products, ensuring quality by design.
- Maintain accurate and up-to-date quality documentation and records.
- Collaborate effectively with R&D, manufacturing, regulatory affairs, and other departments in a remote setting.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 8 years of progressive experience in pharmaceutical quality assurance and regulatory compliance.
- In-depth knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., FDA, EMA, WHO).
- Proven experience in developing and implementing QMS, conducting audits, and managing deviations/CAPAs.
- Strong understanding of pharmaceutical product development, manufacturing processes, and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex quality concepts.
- Demonstrated ability to work independently, manage multiple priorities, and lead effectively in a remote environment.
- Experience with electronic QMS is a plus.
Process Improvement Industrial Engineer
Posted 18 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.
Remote Process Improvement Engineer - Industrial
Posted 6 days ago
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Job Description
Responsibilities:
- Analyze existing industrial processes to identify bottlenecks, inefficiencies, and areas for improvement.
- Develop and implement data-driven strategies to optimize workflows, reduce waste, and improve quality.
- Design and conduct experiments to test process changes and measure their impact.
- Utilize Lean Six Sigma tools and methodologies (e.g., DMAIC, Kaizen) to drive continuous improvement initiatives.
- Create process documentation, flowcharts, and standard operating procedures.
- Train and mentor staff on process improvement techniques and best practices.
- Collaborate with cross-functional teams, including operations, engineering, and management, to implement solutions.
- Monitor the performance of implemented improvements and ensure sustained results.
- Prepare detailed reports and presentations on process analysis, recommendations, and outcomes.
- Stay abreast of industry trends and advancements in process engineering and optimization.
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, Operations Management, or a related field.
- Proven experience (minimum 4 years) in process improvement, operational excellence, or industrial engineering roles.
- Strong knowledge and practical application of Lean Manufacturing and Six Sigma principles (Green Belt or Black Belt certification is highly preferred).
- Proficiency in data analysis tools such as Excel, Minitab, or similar statistical software.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong project management and organizational abilities.
- Exceptional communication, presentation, and interpersonal skills, with the ability to influence stakeholders remotely.
- Experience in virtual collaboration tools and working effectively in a remote team environment.
- Ability to work independently and manage multiple projects simultaneously.
- Experience within manufacturing or heavy industry settings is a plus.
Process Improvement Engineer - Industrial Automation
Posted 16 days ago
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Job Description
Responsibilities:
- Analyze industrial processes and identify areas for automation and improvement.
- Design and implement automation solutions (robotics, PLCs, SCADA).
- Apply Lean Manufacturing and Six Sigma principles for process optimization.
- Develop detailed process documentation and workflow diagrams.
- Manage projects related to automation implementation and upgrades.
- Conduct performance testing and validation of new systems.
- Collaborate with cross-functional teams to ensure successful integration.
- Identify and troubleshoot issues in automated production environments.
- Provide technical recommendations for continuous improvement initiatives.
- Train operations personnel on new automated systems and processes.
- Bachelor's or Master's degree in Industrial, Mechanical, or Electrical Engineering.
- Proven experience in industrial automation and process improvement.
- Strong knowledge of PLCs, robotics, SCADA systems, and control logic.
- Expertise in Lean Manufacturing, Six Sigma, and SPC methodologies.
- Proficiency in CAD software and process simulation tools.
- Excellent analytical, problem-solving, and project management skills.
- Strong communication and interpersonal abilities for stakeholder engagement.
- Experience in manufacturing environments and DFM (Design for Manufacturing).
- Ability to manage multiple projects and priorities effectively.
- Experience in data analysis for process performance monitoring.
Remote Process Improvement Engineer - Industrial Operations
Posted 8 days ago
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Job Description
Responsibilities:
- Analyze current industrial processes to identify areas for improvement in efficiency, cost reduction, and quality.
- Develop and implement Lean Manufacturing and Six Sigma initiatives.
- Utilize data analysis, process mapping, and statistical tools to diagnose operational issues.
- Design and propose new process workflows and system enhancements.
- Lead cross-functional teams in implementing process improvements, ensuring buy-in and adoption.
- Develop and monitor key performance indicators (KPIs) to track the impact of implemented changes.
- Create detailed documentation for new processes and standard operating procedures (SOPs).
- Conduct root cause analysis for production issues and implement corrective actions.
- Stay abreast of industry best practices and emerging technologies in industrial engineering.
- Facilitate remote workshops and training sessions on process improvement methodologies.
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, or a related field.
- Minimum of 5 years of experience in process improvement, Lean Manufacturing, or Six Sigma roles within an industrial setting.
- Proven track record of successfully implementing process changes that resulted in measurable improvements.
- Strong analytical, problem-solving, and critical thinking skills.
- Proficiency in data analysis software and process simulation tools.
- Excellent communication and presentation skills, with the ability to influence stakeholders remotely.
- Experience with project management and leading cross-functional teams.
- Certification in Lean Six Sigma (Green Belt or Black Belt) is highly desirable.
- Ability to work independently, manage time effectively, and maintain high productivity in a remote environment.
- Strong understanding of manufacturing principles and operations.
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Senior Process Improvement Engineer (Industrial Engineering)
Posted 5 days ago
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Job Description
Responsibilities:
- Analyze existing manufacturing and operational processes to identify areas for improvement in efficiency, quality, and cost reduction.
- Apply Lean Manufacturing, Six Sigma, and other continuous improvement methodologies to develop and implement process enhancements.
- Design and simulate new process layouts and workflows to optimize material flow, minimize waste, and improve ergonomics.
- Develop standard operating procedures (SOPs) and work instructions to ensure consistent implementation of improved processes.
- Lead cross-functional teams in process improvement projects, fostering a culture of continuous learning and problem-solving.
- Collect, analyze, and interpret production data to track the performance of implemented changes and identify further optimization opportunities.
- Utilize process mapping tools, statistical analysis, and other engineering techniques to diagnose issues and develop data-driven solutions.
- Provide remote technical expertise and guidance to on-site operational teams.
- Prepare detailed reports and presentations on process improvement initiatives, findings, and recommendations.
- Stay abreast of industry best practices and emerging technologies in industrial engineering and process optimization.
- Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or a related field; Master's degree preferred.
- A minimum of 7 years of progressive experience in industrial engineering, with a strong focus on process improvement and optimization.
- Certified Lean Six Sigma Black Belt or equivalent certification is highly desirable.
- Proven track record of successfully leading and implementing complex process improvement projects in a manufacturing or industrial setting.
- Proficiency in process simulation software, CAD tools, and statistical analysis software (e.g., Minitab, JMP).
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong communication and interpersonal skills, with the ability to influence and collaborate with diverse teams remotely.
- Ability to manage multiple projects simultaneously and work independently in a remote environment.
- Experience with project management methodologies.
- Understanding of supply chain and operations management principles.
Process Improvement Engineer - Manufacturing
Posted 21 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 Engineer - Manufacturing Excellence
Posted 22 days ago
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Job Description
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.