8 Senior Pharmaceutical Quality Control Manager jobs in whatjobs
Senior Pharmaceutical Quality Control Manager
Posted 22 days ago
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Senior Pharmaceutical Quality Control Manager
Posted 14 days ago
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In this entirely remote position, you will direct and mentor a team of QC analysts and specialists, providing technical guidance and ensuring the efficient execution of quality control procedures. Your responsibilities will include reviewing and approving analytical data, validating testing methods, managing stability programs, and preparing for regulatory inspections. You will also play a key role in identifying and implementing process improvements to enhance product quality and operational efficiency. Strong communication skills are essential for liaising with internal departments, external partners, and regulatory agencies. We are looking for a dedicated professional committed to upholding the highest standards of pharmaceutical quality and safety, capable of leading a team and driving quality initiatives in a remote setting. Your contributions will be vital to ensuring the safety and efficacy of life-saving medications.
Responsibilities:
- Develop, implement, and manage comprehensive pharmaceutical quality control systems.
- Oversee all aspects of analytical testing for raw materials, in-process samples, and finished products.
- Ensure compliance with GMP, FDA, and other relevant regulatory guidelines.
- Review and approve analytical data, method validation reports, and specifications.
- Manage stability testing programs and interpret results.
- Lead and mentor the quality control team, providing technical expertise and direction.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Prepare for and participate in regulatory inspections and audits.
- Contribute to the development and validation of new analytical methods.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality.
- Master's or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 8 years of progressive experience in pharmaceutical quality control and assurance.
- Extensive knowledge of GMP, ICH guidelines, and regulatory requirements.
- Proven experience in managing and leading a QC laboratory team.
- Expertise in various analytical techniques (e.g., HPLC, GC, spectroscopy, dissolution testing).
- Strong understanding of method validation and stability studies.
- Excellent problem-solving, decision-making, and risk assessment skills.
- Superior communication, interpersonal, and leadership abilities.
- Proven ability to manage quality operations remotely and ensure compliance.
- Experience with electronic laboratory notebooks (ELN) and LIMS is a plus.
Senior Pharmaceutical Quality Control Manager
Posted 14 days ago
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Senior Pharmaceutical Quality Control Manager
Posted 5 days ago
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Senior Pharmaceutical Quality Control Manager
Posted 13 days ago
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Responsibilities:
- Develop, implement, and manage comprehensive quality control systems and procedures in line with regulatory requirements (e.g., GMP, ISO).
- Oversee the testing of raw materials, intermediates, and finished pharmaceutical products to ensure they meet established specifications.
- Manage and mentor the quality control team, providing guidance and performance feedback.
- Ensure all analytical testing methods are validated and current.
- Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Review and approve batch records, analytical data, and quality control reports.
- Collaborate with R&D, production, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Stay informed about current Good Manufacturing Practices (cGMP) and other relevant pharmaceutical regulations.
- Conduct internal audits and participate in external regulatory inspections.
- Maintain and calibrate laboratory equipment, ensuring compliance with relevant standards.
- Master's or PhD degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 7 years of progressive experience in pharmaceutical quality control or quality assurance.
- In-depth knowledge of pharmaceutical manufacturing processes and regulatory requirements.
- Proven experience in method development, validation, and troubleshooting of analytical techniques (e.g., HPLC, GC, UV-Vis, KF).
- Strong understanding of GMP guidelines and their application in a pharmaceutical setting.
- Excellent leadership, team management, and decision-making skills.
- Proficiency in data analysis and interpretation.
- Exceptional written and verbal communication skills, with the ability to prepare technical reports and documentation.
- Strong problem-solving abilities and a commitment to continuous improvement.
- Ability to work independently, manage multiple priorities, and ensure timely completion of tasks in a remote environment.
Senior Pharmaceutical Quality Control Manager
Posted 22 days ago
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Senior Pharmaceutical Quality Control Manager
Posted 3 days ago
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Key Responsibilities:
- Develop, validate, and implement comprehensive quality control procedures and test methods for raw materials, in-process samples, and finished products.
- Oversee the daily operations of the quality control laboratory, ensuring efficient workflow and timely analysis.
- Manage and maintain all laboratory equipment, ensuring calibration and preventative maintenance are performed according to schedule.
- Ensure all QC activities are performed in compliance with relevant regulatory guidelines (e.g., FDA, EMA, WHO GMP).
- Review and approve analytical test results, Certificates of Analysis (CoA), and batch release documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventative actions (CAPA).
- Prepare and present QC-related data and reports for internal audits, regulatory inspections, and management reviews.
- Lead and mentor a team of QC analysts and technicians, providing training and performance management.
- Collaborate with R&D, Production, and Regulatory Affairs departments to support product development and ensure smooth technology transfer.
- Contribute to the continuous improvement of quality systems and processes within the pharmaceutical manufacturing environment.
- Stay current with advancements in analytical techniques and quality control methodologies.
- Master's degree in Pharmacy, Chemistry, Biochemistry, or a related life science field. A Ph.D. is a plus.
- Minimum of 6-8 years of experience in pharmaceutical quality control, with a significant portion in a supervisory or managerial role.
- Extensive knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceuticals.
- Proven experience with various analytical techniques, including HPLC, GC, UV-Vis, IR spectroscopy, and dissolution testing.
- Strong understanding of laboratory safety procedures and waste management.
- Excellent leadership, team management, and communication skills.
- Proficiency in data analysis, report writing, and investigation of quality issues.
- Ability to manage complex projects and work effectively under pressure in a remote setting.
- Meticulous attention to detail and a commitment to maintaining high-quality standards.
- Experience with quality management systems (QMS) software.
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Senior Pharmaceutical Quality Control Manager
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