Job
Description
As a Quality Audit Manager at Shalina Laboratories Private Ltd., your role will involve the following key responsibilities: - Preparation and adherence to annual planner for Quality audits for Loan Licence Units (LLU), Third Party Manufacturing, and Sites to conduct periodic, due diligence & for cause quality audits to ensure GMP compliance and to monitor the overall performance of the manufacturing. - Planning of audits as per the approved audit planner, reviewing audit outcomes, preparing audit reports, and coordinating with vendors for compliance within the timeframe. - Reviewing audit compliance reports for any external/regulatory/customer audits received from the location and monitoring the closure of individual observations by reviewing relevant supporting data. - Initiating actions based on audit findings and compliances reviewed from the location for approval, rejection, and conditional approval of the manufacturing/testing facility. - Conducting self-inspections of individual departments, compiling reports, tracking and reviewing compliance for timely closure. - Ensuring the all-time audit readiness of Shalina laboratories sites. - Coordinating for compilation and review of technical documents received from vendors for evaluation, arranging analysis of samples, comparative evaluation of results, and maintaining all technical records for each vendor as per SOP. - Introducing, implementing, and conducting effectiveness checks for the Quality Management System (QMS) at all Shalina manufacturing sites. - Preparing for the presentation of monthly quality review meetings (QRM) to present the overall status of the section and highlight any open issues not resolved within the timeline. - Coordinating, tracking, and monitoring all QMS, Vendor Management, and documentation related activities in the absence of a designee from the respective section, if required. - Conducting training at periodic intervals on important quality aspects to raise awareness and provide updates on current guidelines and GMP requirements. - Supporting other cross-functional teams with technical inputs for the implementation and maintenance of the quality system at Shalina Laboratories Private Ltd. - Handling any other specific work assigned by the Global Head - Quality. Qualifications required: - 12+ years of experience in Quality - Qualification: B. Pharmacy or M. Pharmacy Or any science graduate with relevant experience - Thorough Knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations Handling of contract manufacturing Sites Competencies: - Good exposure to GMP environment and regulatory inspections - Flexibility for business traveling across India & Overseas Locations - Working knowledge of GMP/GLP environment - Ability to make independent decisions - Strong cross-functional working skills and effective communication with external stakeholders As a Quality Audit Manager at Shalina Laboratories Private Ltd., your role will involve the following key responsibilities: - Preparation and adherence to annual planner for Quality audits for Loan Licence Units (LLU), Third Party Manufacturing, and Sites to conduct periodic, due diligence & for cause quality audits to ensure GMP compliance and to monitor the overall performance of the manufacturing. - Planning of audits as per the approved audit planner, reviewing audit outcomes, preparing audit reports, and coordinating with vendors for compliance within the timeframe. - Reviewing audit compliance reports for any external/regulatory/customer audits received from the location and monitoring the closure of individual observations by reviewing relevant supporting data. - Initiating actions based on audit findings and compliances reviewed from the location for approval, rejection, and conditional approval of the manufacturing/testing facility. - Conducting self-inspections of individual departments, compiling reports, tracking and reviewing compliance for timely closure. - Ensuring the all-time audit readiness of Shalina laboratories sites. - Coordinating for compilation and review of technical documents received from vendors for evaluation, arranging analysis of samples, comparative evaluation of results, and maintaining all technical records for each vendor as per SOP. - Introducing, implementing, and conducting effectiveness checks for the Quality Management System (QMS) at all Shalina manufacturing sites. - Preparing for the presentation of monthly quality review meetings (QRM) to present the overall status of the section and highlight any open issues not resolved within the timeline. - Coordinating, tracking, and monitoring all QMS, Vendor Management, and documentation related activities in the absence of a designee from the respective section, if required. - Conducting training at periodic intervals on important quality aspects to raise awareness and provide updates on current guidelines and GMP requirements. - Supporting other cross-functional teams with techn
