Assistant Manager - GLP

Zydus Lifesciences; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Zydus Lifesciences is seeking QC/QA professionals in India to prepare and revise CQ documents and implement corporate procedures across sites. You will verify site procedures, assess 483 observations for CAPA, and ensure compliance at drug manufacturing sites and subsidiaries.

You will lead QC investigations, drive CAPA trends, perform lab walkthroughs, train site personnel, review QC data, and evaluate automated instruments and software for QC automation and CSVMP scope.

Responsibilities

• Prepare, Revise CQ Documents (i.e., Policy, Standard Practices, Directive, SOP and GTPs) related to QC function, based on the identified GAPs and current requirement.
• To Implement the Corporate Procedures (i.e., Policy, Standard Practices, Directive, SOP and GTPs) at Sites and Verify the Site Procedures against the implemented corporate procedures for the gaps, if any and ensure compliance on identified gaps.
• Assessment of QC Specific 483s issued to other companies and identify the Global CAPA for further prevention of same observations at Zydus Sites (whenever needed).
• On Site/Off Site Verification of Global CAPA / Compliance of Quality Intelligence observations at the Drug Manufacturing Sites of Zydus Lifesciences Ltd and its Subsidiaries.
• Trend QC Investigations (e.g., OOS and Laboratory Incident) and recommend Global/Site Specific CAPA, if deemed necessary based on trend reports.
• Perform Quality Control Laboratory Walkthroughs, observe the practices and provide feedback for necessary training elements / revise the procedures etc.
• To provide training to site personnel (QC/QA) related to QC investigation and/or other QC practices, as when as needed.
• To review the Quality Control data as when as needed.
• To evaluate, review and implement the automated instrument for Quality Control Laboratory
• To carry out the Proof of Concept (POC) for Automated instrument and QC Automation
• To conduct the qualification of software for QC activities automation within the scope of computer system validation (CSVMP)
• To ensure implementation of Automation, provide training to site team and provide support for troubleshooting activities, whenever required.

Job description

Job Responsibilities

• Prepare, Revise CQ Documents (i.e., Policy, Standard Practices, Directive, SOP and GTPs) related to QC function, based on the identified GAPs and current requirement.


• To Implement the Corporate Procedures (i.e., Policy, Standard Practices, Directive, SOP and GTPs) at Sites and Verify the Site Procedures against the implemented corporate procedures for the gaps, if any and ensure compliance on identified gaps.


• Assessment of QC Specific 483s issued to other companies and identify the Global CAPA for further prevention of same observations at Zydus Sites (whenever needed).


• On Site/Off Site Verification of Global CAPA / Compliance of Quality Intelligence observations at the Drug Manufacturing Sites of Zydus Lifesciences Ltd and its Subsidiaries.


• Trend QC Investigations (e.g., OOS and Laboratory Incident) and recommend Global/Site Specific CAPA, if deemed necessary based on trend reports.


• Perform Quality Control Laboratory Walkthroughs, observe the practices and provide feedback for necessary training elements / revise the procedures etc.


• To provide training to site personnel (QC/QA) related to QC investigation and/or other QC practices, as when as needed.


• To review the Quality Control data as when as needed.


• To evaluate, review and implement the automated instrument for Quality Control Laboratory


• To carry out the Proof of Concept (POC) for Automated instrument and QC Automation


• To conduct the qualification of software for QC activities automation within the scope of computer system validation (CSVMP)


• To ensure implementation of Automation, provide training to site team and provide support for troubleshooting activities, whenever required.