2 Senior Pharmaceutical Quality Control Scientist Remote jobs in whatjobs
Senior Pharmaceutical Quality Control Scientist - Remote
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research and development company, is seeking a highly experienced Senior Pharmaceutical Quality Control Scientist to join their fully remote R&D team. This vital role will involve overseeing and executing rigorous quality control testing for pharmaceutical products, ensuring compliance with stringent regulatory standards (e.g., FDA, EMA) and company policies. You will be responsible for method development and validation, data analysis, stability studies, and troubleshooting analytical issues. The ideal candidate will possess a deep understanding of analytical chemistry techniques, pharmaceutical manufacturing processes, and quality assurance principles, along with excellent problem-solving and documentation skills. This is a significant opportunity to contribute to the development of life-saving medicines from a remote setting, ensuring the safety and efficacy of pharmaceutical products globally. Your scientific expertise and commitment to quality will be crucial.
Key Responsibilities:
Key Responsibilities:
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, FTIR, and mass spectrometry.
- Perform routine quality control testing according to established protocols and Standard Operating Procedures (SOPs).
- Analyze and interpret complex analytical data, generating accurate and comprehensive reports.
- Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Conduct stability studies to determine product shelf-life and storage conditions.
- Maintain and calibrate laboratory equipment, ensuring optimal performance and compliance with GLP/GMP guidelines.
- Review and approve analytical data, batch records, and validation reports.
- Contribute to the development and continuous improvement of quality control processes and procedures.
- Stay current with scientific advancements, regulatory guidelines, and industry best practices in pharmaceutical quality control.
- Provide technical expertise and mentorship to junior QC scientists.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to support product development and lifecycle management.
- Prepare and present findings for internal reviews and regulatory submissions.
- Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field.
- Minimum of 7 years of experience in pharmaceutical quality control, analytical development, or a related laboratory setting.
- Extensive hands-on experience with various analytical instrumentation (HPLC, GC, MS, etc.) and data analysis software.
- Strong understanding of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory guidelines (FDA, EMA).
- Proven ability in method development and validation for pharmaceutical products.
- Excellent data interpretation, troubleshooting, and problem-solving skills.
- Strong written and verbal communication skills, essential for remote documentation and collaboration.
- Meticulous attention to detail and a commitment to scientific accuracy.
- Ability to work independently and manage multiple projects in a remote environment.
- Experience with laboratory information management systems (LIMS) is a plus.
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Senior Pharmaceutical Quality Control Scientist (Remote)
Posted 18 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and meticulous Senior Pharmaceutical Quality Control Scientist to lead critical quality assurance efforts. This is a fully remote position, offering the flexibility to work from anywhere. You will be responsible for ensuring the quality and integrity of pharmaceutical products through rigorous testing and analysis. Your role will involve developing and validating analytical methods, conducting stability studies, reviewing batch records, and ensuring compliance with regulatory standards such as GMP (Good Manufacturing Practices). You will work closely with R&D, manufacturing, and regulatory affairs teams.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished products.
- Conduct stability studies according to ICH guidelines and analyze data to determine shelf-life.
- Perform comprehensive quality control testing using various analytical techniques (e.g., HPLC, GC, spectroscopy, dissolution testing).
- Review and approve batch records, ensuring all quality control parameters are met.
- Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective actions.
- Ensure compliance with all relevant regulatory requirements, including GMP, FDA, and other health authority guidelines.
- Prepare and maintain detailed analytical reports, method validation reports, and stability study protocols/reports.
- Contribute to the continuous improvement of quality control processes and systems.
- Stay updated on advancements in pharmaceutical analysis and regulatory expectations.
- Train and mentor junior QC scientists.
Qualifications:
- Master's degree or Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
- Minimum of 7 years of experience in pharmaceutical quality control, with a strong focus on analytical method development and validation.
- Extensive experience with various analytical instrumentation (HPLC, GC, UV-Vis, IR, KF titrator, dissolution apparatus).
- In-depth knowledge of GMP, ICH guidelines, and regulatory submission requirements.
- Proven ability to conduct and interpret stability studies.
- Strong understanding of pharmaceutical product development lifecycle.
- Excellent analytical, problem-solving, and documentation skills.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple projects effectively in a remote setting.
- Detail-oriented with a commitment to accuracy and quality.
This advertiser has chosen not to accept applicants from your region.
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