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Showing 844 Small Scale Manufacturing jobs in Nyeri

Senior Pharmaceutical Quality Control Specialist

10100 Nyeri Town KES650000 Annually WhatJobs Direct

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full-time
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Senior Pharmaceutical Quality Control Specialist to join their team. This role is crucial in ensuring that all manufactured pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be responsible for conducting rigorous testing, analyzing results, and implementing quality control procedures throughout the production process. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), regulatory requirements, and analytical laboratory techniques. This position involves a hybrid work model, offering a balance between in-office laboratory work and remote administrative tasks, such as data analysis, report generation, and protocol development. Responsibilities include performing in-process and finished product testing, maintaining laboratory equipment, validating test methods, and ensuring compliance with all relevant quality standards. You will also be involved in troubleshooting quality issues, collaborating with cross-functional teams, and contributing to continuous improvement initiatives. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. Excellent analytical, problem-solving, and documentation skills are essential. The ability to work independently and as part of a team, both on-site and remotely, is vital. This is an excellent opportunity for a dedicated quality professional to contribute to the development and manufacturing of life-saving medicines and advance their career within a reputable organization.
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Lead Pharmaceutical Quality Control Scientist

20100 Karagita KES90000 Annually WhatJobs Direct

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full-time
Our client, a prominent pharmaceutical firm, is searching for a seasoned Lead Pharmaceutical Quality Control Scientist to spearhead their remote quality assurance operations. This role demands a meticulous and experienced professional dedicated to upholding the highest standards of pharmaceutical quality and compliance. You will be responsible for overseeing all aspects of quality control testing, method validation, and stability studies for a diverse range of pharmaceutical products. This includes developing and implementing robust quality control procedures, ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. The Lead Scientist will manage a team of quality control analysts, providing technical guidance, training, and performance management. Your expertise will be crucial in troubleshooting analytical issues, investigating deviations, and implementing corrective and preventive actions (CAPA). You will also be involved in the review and approval of batch records, analytical reports, and quality agreements. A significant part of this role involves collaborating with R&D, manufacturing, and regulatory affairs departments to ensure seamless product development and lifecycle management. This is a remote position, offering the flexibility to work from anywhere while making a critical contribution to public health. The successful candidate will possess a deep understanding of analytical techniques, instrumentation (e.g., HPLC, GC, MS), and pharmacopeial standards. Experience in pharmaceutical formulation and process development is highly desirable. You should demonstrate excellent leadership, communication, and problem-solving skills. Your commitment to quality and patient safety will be paramount. We are looking for individuals who are passionate about advancing pharmaceutical science and who can thrive in a virtual, collaborative environment. The ability to interpret complex data and translate it into actionable insights is essential.Naivasha, Nakuru, KE is the designated regional hub, but the role is fully remote.
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Senior Pharmaceutical Quality Control Analyst

20100 Nyeri Town KES250000 Annually WhatJobs Direct remove_red_eye View All

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full-time
Our client, a leading innovator in the pharmaceutical sector, is seeking a highly motivated and experienced Senior Pharmaceutical Quality Control Analyst to join their dynamic, remote-first team. This role is crucial in ensuring the consistent quality and efficacy of our pharmaceutical products through rigorous testing and data analysis. You will be responsible for developing, validating, and implementing analytical methods for raw materials, in-process samples, and finished products. This includes performing complex analytical testing using various sophisticated instrumentation such as HPLC, GC, UV-Vis spectrophotometry, and dissolution apparatus. Your expertise will be vital in interpreting results, troubleshooting any deviations, and contributing to the continuous improvement of quality control processes. The ideal candidate will maintain meticulous records, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) regulations. You will also participate in internal and external audits, providing detailed explanations of QC procedures and findings. Furthermore, this position involves collaborating with R&D and production teams to address any quality-related issues, contributing to product development cycles, and ensuring timely release of products. A strong understanding of pharmacopoeial standards (e.g., USP, EP, BP) is essential. The successful applicant will be expected to mentor junior analysts, share best practices, and foster a culture of quality excellence within the team. This is an exceptional opportunity for a seasoned professional to make a significant impact from the comfort of their home office, contributing to the advancement of healthcare solutions globally. We are looking for individuals who are passionate about pharmaceutical science, possess exceptional analytical skills, and thrive in a collaborative, remote environment. This role requires a proactive approach to problem-solving and a commitment to upholding the highest standards of quality and safety. The position is based in **Nyeri, Nyeri, KE**, but is performed remotely.
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Principal Pharmaceutical Quality Assurance Specialist

00200 Ongata Rongai, Rift Valley KES320000 Annually WhatJobs Direct

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Job Description

full-time
Our client is seeking a highly experienced and motivated Principal Pharmaceutical Quality Assurance Specialist to lead and enhance their quality systems. This is a fully remote, critical role, offering the flexibility to work from anywhere while maintaining the highest standards of pharmaceutical product quality and compliance. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, ensuring adherence to global regulatory requirements (e.g., FDA, EMA, WHO GMP). Your expertise will be vital in overseeing all aspects of quality control, risk management, and continuous improvement initiatives within the pharmaceutical manufacturing lifecycle. This role requires a deep understanding of pharmaceutical regulations, quality management systems, and a proactive approach to ensuring product safety and efficacy.

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.
This is a senior-level opportunity to shape quality standards. The role is based in Ongata Rongai, Kajiado, KE , but is fully remote.
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Remote Pharmaceutical Quality Assurance Specialist

10100 Nyeri Town KES115000 Annually WhatJobs Direct remove_red_eye View All

Posted 1 day ago

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Job Description

full-time
Our client, a reputable pharmaceutical company committed to delivering high-quality medicines, is seeking a meticulous and experienced Remote Pharmaceutical Quality Assurance Specialist. This fully remote role is crucial for ensuring that all pharmaceutical products and processes meet stringent quality standards, regulatory requirements, and company policies. You will be responsible for reviewing batch records, investigating deviations, managing change controls, and participating in internal audits. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and relevant pharmaceutical quality systems. You will collaborate closely with manufacturing, R&D, and regulatory affairs teams to ensure compliance and drive continuous improvement in quality processes. This position demands exceptional attention to detail, strong analytical and problem-solving skills, and the ability to manage documentation and investigations efficiently in a remote setting. Your commitment to quality will be paramount in safeguarding patient safety and product integrity.

Responsibilities:
  • Review and approve batch production and control records to ensure compliance with specifications and GMP.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, documenting findings and recommending corrective and preventive actions (CAPAs).
  • Manage change control processes, assessing the impact of proposed changes on product quality and regulatory compliance.
  • Participate in internal audits and assist with external regulatory inspections.
  • Develop, review, and update Standard Operating Procedures (SOPs) and quality system documents.
  • Monitor and ensure compliance with global regulatory requirements (e.g., FDA, EMA).
  • Collaborate with cross-functional teams to address quality issues and implement improvements.
  • Maintain quality assurance records and documentation.
  • Assist in the qualification and validation of equipment and processes.
  • Stay current with pharmaceutical quality standards and regulatory updates.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 4 years of experience in pharmaceutical Quality Assurance or Quality Control.
  • In-depth knowledge of GMP, GDP, and other relevant pharmaceutical quality regulations.
  • Experience with batch record review, deviation management, change control, and CAPA systems.
  • Familiarity with pharmaceutical manufacturing processes and analytical testing.
  • Strong understanding of regulatory submission requirements is a plus.
  • Excellent analytical, problem-solving, and critical-thinking skills.
  • Meticulous attention to detail and strong organizational skills.
  • Proficiency in using quality management software and standard office applications.
  • Exceptional written and verbal communication skills, with the ability to document findings clearly and concisely.
  • Ability to work independently and manage workload effectively in a remote environment.
This fully remote position offers a vital role in ensuring the highest standards of pharmaceutical quality from anywhere. If you are a dedicated QA professional with a passion for drug safety and compliance, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Specialist

20110 Karagita KES260000 Annually WhatJobs Direct remove_red_eye View All

Posted 1 day ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their remote team. In this critical role, you will be responsible for ensuring that all pharmaceutical products manufactured and distributed meet stringent quality standards and regulatory requirements. You will play a pivotal part in maintaining our commitment to product safety and efficacy through robust quality systems and processes. Your duties will include reviewing and approving batch records, developing and implementing quality control procedures, conducting internal audits, and managing deviation investigations and CAPA (Corrective and Preventive Actions). You will also be involved in validating manufacturing processes and equipment, and ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing processes, quality management systems, and regulatory affairs. You must have excellent analytical skills, meticulous attention to detail, and the ability to interpret and apply complex regulatory guidelines. This is a fantastic opportunity for a seasoned QA professional to contribute significantly to drug quality and safety in a remote work environment, offering flexibility and impact. You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure seamless quality oversight throughout the product lifecycle. Strong communication and problem-solving skills are essential. We are looking for a proactive individual dedicated to upholding the highest standards of quality in the pharmaceutical industry.
Responsibilities:
  • Ensure compliance with GMP, GLP, and other relevant pharmaceutical regulations.
  • Review and approve batch manufacturing records and quality control data.
  • Develop, implement, and maintain quality assurance policies and procedures.
  • Conduct internal audits of manufacturing processes, facilities, and documentation.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints.
  • Develop and implement Corrective and Preventive Actions (CAPA).
  • Participate in validation activities for manufacturing processes, equipment, and computer systems.
  • Collaborate with R&D, manufacturing, and regulatory affairs teams on quality-related matters.
  • Provide training to personnel on GMP and quality system requirements.
  • Stay updated on evolving regulatory requirements and industry best practices.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 5 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory standards.
  • Experience with pharmaceutical manufacturing processes and quality systems.
  • Strong understanding of validation principles and practices.
  • Excellent analytical, problem-solving, and investigative skills.
  • Meticulous attention to detail and accuracy.
  • Strong written and verbal communication skills.
  • Ability to work independently and manage multiple priorities effectively in a remote setting.
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Senior Pharmaceutical Quality Assurance Specialist - Remote

20116 Karagita KES240000 Annually WhatJobs Direct remove_red_eye View All

Posted 1 day ago

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Job Description

full-time
Our client is seeking a highly diligent and experienced Senior Pharmaceutical Quality Assurance Specialist to join their fully remote quality control team. This critical role will be responsible for ensuring that all pharmaceutical products meet stringent quality standards and comply with regulatory requirements. You will play a key role in developing, implementing, and maintaining quality assurance systems, conducting audits, managing documentation, and investigating deviations. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing, regulatory affairs (e.g., GMP, FDA, EMA), and a commitment to upholding the highest standards of quality, all within a remote work framework.

Key Responsibilities:
  • Develop, implement, and maintain robust Quality Assurance systems and procedures for pharmaceutical products.
  • Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory 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).
  • Manage change control processes and ensure thorough documentation.
  • Participate in regulatory inspections and liaise with regulatory authorities.
  • Develop and deliver training on quality assurance principles and GMP requirements.
  • Monitor key quality metrics and generate reports for management review.
  • Stay updated on current regulatory expectations and industry best practices.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
  • Contribute to the continuous improvement of quality systems and processes.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
  • A minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, FDA, EMA, and other relevant pharmaceutical regulations.
  • Proven experience in conducting audits, managing deviations, and implementing CAPAs.
  • Strong understanding of pharmaceutical manufacturing processes and validation.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional attention to detail and organizational skills.
  • Strong written and verbal communication skills, with the ability to articulate complex quality issues effectively in a remote setting.
  • Proficiency in quality management software and documentation systems.
  • Ability to work independently, manage multiple priorities, and meet deadlines in a remote environment.
  • Relevant professional certifications are a plus.
This is an exceptional opportunity for a dedicated QA professional to contribute to the safety and efficacy of pharmaceutical products from a fully remote position. Join a mission-driven organization committed to excellence in quality and compliance.
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Principal Pharmaceutical Quality Assurance Manager

20100 Nyeri Town KES120000 Annually WhatJobs Direct

Posted 1 day ago

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Job Description

full-time
Our client, a prominent entity in the pharmaceutical sector, is seeking an experienced Principal Pharmaceutical Quality Assurance Manager to lead their remote quality operations. This crucial role will oversee the development, implementation, and maintenance of robust quality management systems across all stages of pharmaceutical product lifecycle, from development to post-market surveillance. As a fully remote leader, you will be responsible for ensuring compliance with global regulatory standards, including GMP, GDP, and ICH guidelines. Your duties will involve conducting internal and external audits, managing deviation investigations, implementing CAPA strategies, and driving continuous improvement initiatives. You will also provide expert guidance on quality-related matters to project teams and senior management. The ideal candidate will possess a Master's degree or PhD in Pharmacy, Chemistry, or a related scientific field, with extensive experience in pharmaceutical quality assurance and regulatory affairs. Demonstrated leadership skills, a deep understanding of pharmaceutical manufacturing processes, and a strong track record in successful regulatory inspections are required. This is an exceptional remote opportunity to shape the quality culture of a growing pharmaceutical organization and ensure the highest standards of product safety and efficacy. You will be a key player in maintaining compliance and driving excellence in quality assurance, contributing significantly to the company's reputation and success. The ability to work independently, manage complex projects, and communicate effectively with stakeholders at all levels is paramount for this role. Join us to make a tangible difference in the quality and safety of medicines worldwide.
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