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Senior QA Manager, CMC GMP Operations

Job Description:

Provide QA support to Corcept GMP Development, Manufacturing and Supply Chain operations for outsourced production of API, intermediates, and drug products as well as packaging, labeling and kitting of new chemical entities (NCEs) for use in human clinical studies.


Responsibilities:

  • Review/approval of specifications, analytical methods, validation protocols and validation reports for methods used for release and stability testing of starting materials, APIs, intermediates, drug products and Clinical Trial Materials (CTM).
  • Compliance review of master and executed production and analytical records for disposition of APIs, intermediates, drug products, packaging, patient kits, and labeling.
  • Participate in cross functional investigations to determine root cause for deviations and OOS reports and advise on corrective actions and change control.
  • Author and revise SOPs, internal specifications and COAs.
  • Generate and review Quality and Technical Agreements with contract manufacturers and laboratories.
  • Conduct external qualification audits of contract manufacturers (API, oral dosage forms, packaging, labeling) and laboratories.
  • Contribute to the QA team focusing on continual improvement of processes, QMS and compliance.


Requirements:

  • BA/BS in a scientific discipline.
  • Thorough knowledge of 21 CFR 210/211.
  • 10+ years' experience in pharmaceutical QA including 5+ supporting manufacturing.
  • Excellent written and oral communication skills.


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Knowledge of principles of qualification and validation of computerized systems, processes, and cleaning methods.
  • Qualification, routine and for-cause audits of suppliers and reporting findings.
  • General understanding of Clinical Operations.


If you are interested, please submit your resume by email to hr@corcept.com

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