Job Description

• To review and implement a Quality Management System for cGMP compliance at the Production (Injectable) plant.
• To prepare, Review and Approve BMR, BPR and related documents.
• Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, Schedule and Track and trace Serialization & aggregation.
• Giving the required training also Responsible for Media fill and GMP.
• Handling of Quality Risk Management (QRM)
• Responsible for Job allocation of the Production Team
• To ensure the GMP at all levels in the Injectable plant.
• To review and approve production documentation for compliance with cGMP requirements.
• To prepare & review SOPs, Validation Protocols and other related documents at the Production (injectable) plant.
• To review Change Control, Incidents/Deviations and ensure its closure, within a given timeframe as per respective SOP.
• Review the signatory for all SOPs, Master Batch Records, Qualification, Validation, documents on analytical and manufacturing equipment, specifications, change control, OOS investigations, and other investigations.
• To check and review dispensing (Raw material & packing material).
• Ensure the execution of Process validation and equipment validation.
• Review batch production Records to ensure the batch has been manufactured and tested according to the laid-down procedure/specification. Record any deviations and investigate.
• To conduct and monitor calibration, qualification, validation and requalification activity at site.
• To review the Product License Application and support the Regulatory department in obtaining the product license from the local Regulatory Authority.
• To review and submit the data/information to Quality Assurance for preparation of
• DMF/dossiers/applications for registration of the product with the Regulatory Authority of the countries in which the product is intended to be marketed.
• To ensure implementation of the CAPA initiated because of self-audit, customer, and regulatory audit.
• To inform Management on quality issues (if any).
• Ensure compliance with online manufacturing, Filling, Lyophilization, Sealing, Visual Inspection and packing activities.
• Participation and monitoring of all activities of small volume parenteral (SVP) project.
• Check and review all documents per training for small-volume parenteral facilities.
• Responsible for Aseptic behavior in classified areas

Skills Required