Your Responsibilities : 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.
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
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.