What Jobs are available for Small Scale Manufacturing in Nyeri?
Showing 844 Small Scale Manufacturing jobs in Nyeri
Senior Pharmaceutical Quality Control Specialist
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Lead Pharmaceutical Quality Control Scientist
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Senior Pharmaceutical Quality Control Analyst
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Principal Pharmaceutical Quality Assurance Specialist
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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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Remote Pharmaceutical Quality Assurance Specialist
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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.
- 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.
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Senior Pharmaceutical Quality Assurance Specialist
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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.
- 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
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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.
- 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.
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Principal Pharmaceutical Quality Assurance Manager
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