Syngene is an internationally reputed contract research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services.
Post : ASSOCIATE MANAGER - Facility Compliance and Documentation Control
Job description
Job Purpose: The objective of this role is to ensure GMP compliance within Syngene's Bio-pharmaceutical Manufacturing Plants including but not limited to cleaning, sanitization, management of cleanrooms and cleanroom behavior (aseptic practices), GMP documentation, documentation control and data integrity.
Responsibilities:
• Ensure the performance of regular facility walkthroughs and facilitate internal quality audits for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
• Ensure timely proposal and implementation of appropriate CAPA for audit findings.
• Ensure the establishment and implementation of a robust cleaning & sanitization program including the following aspects:
• Supervising of disinfectant preparation and cleaning and sanitization.
• Maintenance and review of appropriate documentation.
• Ensure review of executed GMP records within the manufacturing facility (Batch Records, Equipment Usage Logbooks, etc.) to ensure adherence to Good Documentation Practice(s), Data Integrity and compliance with approved Standard Operating Procedures.
• Lead and ensure timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.
• Track and ensure implementation of approved CAPA for Biologics Operations.
• Ensure waste management as per established procedures.
• Ensure review of Environmental Monitoring Data, Trends Reports, and associated documents.
• Ensure adherence with Clean Room Behaviour’s by all the personnel working in the clean rooms.
• Manage product changeover and line clearance for technical (non-GMP) batches.
• Conduct and/or support training on SOPs, protocols and On-the-Job activities.
• Lead and ensure implementation of Operational Excellence initiatives for Biologics Operations.
• Ensure sterilization of the articles for the facility management and manufacturing process activities as per approved procedures.
Secondary Responsibilities:
• Support for timely proposal, appropriate impact assessment and implementation of Change Controls.
• Support for timely reporting of deviations, appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
• Support for appropriate manufacturing investigations for OOS results and Customer Complaints to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
• Support for Risk Management for Biologics Operations covering the following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA).
• Quality and Compliance Risks
• Operational Risks
• Data Integrity Risks
• Support for timely preparation, review, and approval of GMP documentation for Biologics Operations.
• Standard Operating Procedures (EOP, IOP, and SOP) and Protocols and Reports
• Batch Manufacturing Records
• Any other GMP relevant documentation
• Support for control of documents and records within Manufacturing Operations.
• Perform and support timely preparation of GMP documents SOPs, Protocol.
• Verify current version GMP documents in the scan share folder for reference.
• Control GMP documents in the facility.
• Involve in the DMS activity.
• Perform on-time extension requests before the due date for any QMS documents like Change Control, Deviation, CAPA, whenever the closure is not expected by the proposed target dates.
Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Experience : 5+ years
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Facility Compliance and Documentation Control
End Date : 25th November, 2019
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