To ensure that the Products provided to the market are tested as per Customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA /ISO guidelines.
Key Responsibilities:
Requirements
- Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
- Knowledge of documentation related to quality and regulatory guidelines.
- Minimum 9 years of experience in Pharmaceutical industry and extensive Quality Assurance experience in API manufacturing industry.
Skills Required
- Post-Graduation in Chemistry
- Minimum 9 years experience in the pharmaceutical industry with extensive Quality Assurance experience in API manufacturing
- Knowledge of cGMP and GLP guidelines, ICH and USFDA requirements
- Knowledge of documentation related to quality and regulatory guidelines
- Experience with release/rejection of finished products, intermediates and raw material and creation/release of Certificates of Analysis
- Experience in QC analytical data review and handling OOS/OOT investigations
- Experience with SAP for batch release
- Knowledge of SHE (safety, health & environment) guidelines and conducting safety audits
What We Do
Centrient Pharmaceuticals is a global business-to-business manufacturer of foundational medicines, including antibiotics, next-generation statins, and anti-fungals. The company leverages proprietary enzymatic biotechnology to produce active pharmaceutical ingredients (APIs), intermediates, and finished dosage forms (FDFs). Headquartered in the Netherlands, Centrient focuses on sustainable, quality-driven manufacturing and supply chain security, serving as a key partner in the global healthcare system to improve patient lives through innovative medicine production.
