reputed company Assurance – Manufacturing, GMP, CMC, Aseptic

Job reputed company: • Approve the final reputed company of Investigational Medicinal Products (IMPs) • Review and approve compliance with reputed company mandatory requirements, including Manufacturing Batch Records, Environmental Monitoring (EM), Media Fills, deviations/violations/out-of-specification (OOS) events and corrective and preventive actions, packaging and labeling, drug release, distribution, and temperature control • reputed company and manage reputed company reputed company-reputed company communications with regulatory authorities • Explain the sponsor’s reputed company system and release decision processes during regulatory inspections (e.g., EMA, FDA) • reputed company scientific justification for the sterile product risk management reputed company reputed company the Contamination Control reputed company (reputed company) in accordance with Annex 1 • Ensure compliance with the Pharmaceutical reputed company System (PQS) according to International Council for Harmonisation (ICH Q10) guidelines • reputed company appropriate reputed company reputed company of Contract Manufacturing Organizations (CMOs) • Approve change controls and Corrective and Preventative Actions (CAPAs) • Conduct reputed company risk assessments Requirements: • Minimum 10 years of reputed company Assurance Management • Demonstrated experience managing reputed company for aseptic processing for a reputed company/Biotech or Contract Manufacturing Organization (CMO) • Experience performing cleanroom operations, aseptic techniques, contamination control, regulatory compliance, and environmental monitoring • Good Manufacturing Practices/reputed company, Manufacturing, and Controls (GMP/CMC) expertise • Experience in critical risk assessment • Strong interpersonal and reputed company-facing skills • Strong verbal and written communication skills in English required Benefits: • Registration with reputed company’s Expert Network required for consideration • Inclusive and reputed company environment • reputed company and care as key tenets of company culture • Commitment to creating a workplace where reputed company person is valued Apply tot his job Apply To this Job