QA Product Release Lead
Stiefel Laboratories, Inc
Hyderabad, Pakistan
14d ago

Your Responsibilities : Job Purpose

Job Purpose

  • Lead the QA release function for all product manufactured at Jamshoro.
  • Supports QA Operations in assuring compliance of the batch review and release operations for all products.
  • Assists in the development, implementation and enforcement of the batch review and release processes and procedures designed to maintain compliance to regulatory requirements and current Good Manufacturing and Documentation Practices.
  • Key Responsibilities

  • Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
  • Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
  • Direct oversight of the batch review and release function to ensure compliance to regulatory filing requirements and cGMP’s, as well as GSK policies and procedures.
  • Provide support and expertise to IPC Monitors.
  • Drives procedural and process review changes where necessary to ensure consistent adherence to internal / external guidelines, policies, procedures, specifications, and regulatory requirements as part of the batch review and release operation.
  • Supports batch documentation review including, but not limited to, overall review of production in-process tests, QC data (e.
  • g. COA’s, Analytical Sheets), deviations, and change controls.

  • BPCS batch status control to release finished product.
  • Perform all release activity of Jamshoro products.
  • Perform all release activity of 3rd party products and ensure confirmation of technical release of 3rd party product and communicate required documents.
  • Main liaison between production operations and QA batch release for process and system related issues.
  • Ensures GMP and all SOP’s are followed.
  • Support to archiving of batch documents and reference samples in reference room.
  • Positively interacts with internal and external associates to quickly and effectively resolve issues, and implements means to prevent recurrence.
  • Assists in inspections and internal audits by involvement in inspection / audit discussion and by coordinating and ensuring supply of required information and documentation in a timely manner.
  • Drives procedural and process review changes to facilitate compliance as a result of identified areas of enhancement.
  • Responsible for developing and maintaining metrics for batch release.
  • Participate on special projects to represent batch release, where applicable
  • Ensure QA Operations Reports are released as per defined frequency.
  • Attend Supply Meeting and GPS VSM Meeting.
  • Any other responsibility assigned from time to time as per business requirements.
  • Basic qualifications : Pharm-D

    Pharm-D

    Preferred qualifications :

    MSC Chemistry, MSC Microbiology

    Preferably 5 years’ or above experience in Pharmaceutical industry

    Why GSK? :

    At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-

    leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.

    To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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