Manager / Senior Manager / Agm / Dgm / Gm - Production (svp / Injectable / Osd / Oral Solid)

2 weeks ago

Bharuch Gujarat, India SDP HR Solution Full time

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

  • AGM- DGM

    3 days ago

    Nandesari Ind. Estate, Vadodara, Gujarat, India Farmson Basic Drugs Pvt Ltd Full time ₹ 1,50,000 - ₹ 20,00,000 per year

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    2 weeks ago

    Bharuch, India Corporate Chemistry Full time

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    4 days ago

    Gujarat, India Aarti Pharmalabs Ltd. (APL) Full time

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    2 days ago

    gujarat, India Aarti Pharmalabs Ltd. (APL) Full time

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