4 Senior Pharmaceutical Quality Control Scientist jobs in whatjobs
Senior Pharmaceutical Quality Control Scientist
Posted 13 days ago
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Job Description
Key responsibilities include:
- Developing, validating, and implementing analytical methods for raw materials, intermediates, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, and dissolution testing.
- Performing routine quality control testing according to established protocols and regulatory guidelines (e.g., GMP, ICH).
- Investigating and troubleshooting Out-of-Specification (OOS) results and deviations, providing detailed root cause analysis.
- Maintaining laboratory equipment, ensuring proper calibration, and adhering to all safety procedures.
- Reviewing and approving analytical data, batch records, and method validation reports.
- Participating in regulatory inspections and audits, ensuring compliance with all relevant standards.
- Collaborating with R&D, manufacturing, and regulatory affairs departments to resolve quality-related issues.
- Staying current with the latest advancements in pharmaceutical analysis and quality control.
- Contributing to the continuous improvement of quality systems and processes.
- Training and mentoring junior QC analysts on analytical techniques and procedures.
The ideal candidate will possess a Master's or Ph.D. in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a related field, with a minimum of 5 years of experience in pharmaceutical quality control. Extensive hands-on experience with analytical instrumentation (HPLC, GC, spectroscopy) and method validation is essential. A thorough understanding of Good Manufacturing Practices (GMP), ICH guidelines, and other relevant regulatory requirements is mandatory. Excellent analytical, problem-solving, and documentation skills are critical. Strong communication and interpersonal skills are necessary for effective remote collaboration with cross-functional teams. You will be remotely contributing to ensuring the highest standards of quality for our pharmaceutical products, supporting operations that may involve **Machakos, Machakos, KE**. This is an exceptional opportunity to make a significant impact in ensuring drug safety and efficacy. We are looking for a detail-oriented scientist with a passion for quality and a commitment to excellence in pharmaceutical manufacturing.
Senior Pharmaceutical Quality Control Scientist
Posted 5 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, FTIR, Karl Fischer).
- Perform routine quality control testing according to established protocols and pharmacopoeial standards (e.g., USP, BP, EP).
- Analyze and interpret test results, ensuring accuracy and completeness of data.
- Investigate out-of-specification (OOS) results, deviations, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Maintain laboratory equipment, ensuring proper calibration, qualification, and performance verification.
- Prepare and review analytical reports, batch release documentation, and method validation protocols.
- Contribute to the improvement of quality control processes and procedures to enhance efficiency and compliance.
- Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines.
- Train and mentor junior QC analysts on testing procedures, instrument operation, and quality principles.
- Collaborate with R&D, Production, and Regulatory Affairs departments to support product development and lifecycle management.
- Participate in internal and external audits as a subject matter expert.
- Manage laboratory consumables and inventory.
- A Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biotechnology, or a related field. A Master's degree is a significant advantage.
- A minimum of 5 years of experience in pharmaceutical quality control or a related analytical laboratory setting.
- Extensive hands-on experience with common analytical instruments (HPLC, GC) and wet chemistry techniques.
- Thorough understanding of pharmacopoeias (USP, BP, EP) and GMP/GLP regulations.
- Proven experience in method development, validation, and OOS investigations.
- Strong analytical skills with meticulous attention to detail.
- Excellent documentation, reporting, and communication skills.
- Ability to work effectively both independently and as part of a team.
- Proficiency in using laboratory information management systems (LIMS) is a plus.
Senior Pharmaceutical Quality Control Scientist
Posted 2 days ago
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Job Description
The ideal candidate will be responsible for developing, validating, and executing analytical methods for raw materials, in-process samples, and finished products. This includes performing complex analytical procedures using a variety of sophisticated laboratory instrumentation such as HPLC, GC, UV-Vis spectrophotometry, and dissolution testers. You will meticulously document all testing procedures, results, and deviations, maintaining comprehensive and accurate records in compliance with Good Manufacturing Practices (GMP) and other relevant quality guidelines.
Key responsibilities will involve troubleshooting analytical methods, identifying root causes for out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPA). You will also play a crucial role in stability testing programs, analyzing data to determine product shelf-life and storage conditions. Collaboration with R&D, Production, and Regulatory Affairs departments will be essential to address quality-related issues and support new product development and process improvements. Mentoring junior scientists and contributing to departmental training initiatives will also be part of your mandate.
To be successful in this role, you will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biochemistry, or a related scientific discipline. A minimum of 5 years of hands-on experience in pharmaceutical quality control or analytical development is required. Demonstrated expertise in GMP environments and proficiency with various analytical techniques and laboratory equipment are non-negotiable. Strong problem-solving skills, excellent attention to detail, and the ability to work independently and as part of a team are critical. Effective communication skills, both written and verbal, are also essential for report generation and cross-functional collaboration.
This hybrid position offers the opportunity to contribute significantly to the quality assurance of life-saving medications while enjoying a balance between on-site laboratory work and remote administrative tasks. If you are passionate about pharmaceutical quality and possess the requisite expertise, we encourage you to apply.
Senior Pharmaceutical Quality Control Scientist
Posted 1 day ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and validate analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, dissolution testing, etc.
- Perform routine testing of pharmaceutical samples according to approved protocols and specifications.
- Analyze and interpret complex analytical data, identifying any deviations from specifications.
- Prepare detailed analytical reports, including method validation reports, stability reports, and batch release data.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
- Maintain and calibrate laboratory instrumentation, ensuring accurate and reliable results.
- Troubleshoot analytical methods and instrumentation issues, implementing corrective actions.
- Participate in internal and external audits, providing necessary documentation and support.
- Mentor and train junior QC analysts on analytical techniques and procedures.
- Contribute to continuous improvement initiatives within the Quality Control department.
Qualifications:
- Master's or Ph.D. in Pharmacy, Chemistry, Analytical Chemistry, or a related scientific discipline.
- Minimum of 7 years of experience in pharmaceutical quality control, with a strong focus on analytical method development and validation.
- Hands-on experience with a variety of analytical instruments (HPLC, GC, MS, spectroscopy, etc.).
- In-depth knowledge of pharmaceutical regulatory requirements (GMP, ICH guidelines).
- Strong understanding of analytical chemistry principles and statistical analysis.
- Excellent problem-solving, critical thinking, and organizational skills.
- Strong written and verbal communication skills, with the ability to document scientific findings accurately.
- Proven ability to work independently and manage workload effectively in a remote environment.
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