Pharmacy Job at Shalina Healthcare | Apply Now for the Manager QA Role
Shalina Laboratories Private Ltd. is seeking an experienced pharmaceutical professional for a strategic role in Quality Assurance and Auditing. This Pharmacy Job is ideal for B.Pharm, M.Pharm, or Science graduates with a deep understanding of shop-floor operations in OSD, Sterile, and Liquid formulations. The quality assurance job involves managing annual audit planners, ensuring GLP/GDP compliance, and conducting due diligence for contract manufacturing sites. Candidates must have strong exposure to regulatory inspections and be willing to travel across India and overseas to maintain the all-time audit readiness of Shalina’s global sites.
- Job Opportunity: Manager – Quality Assurance
- Location: Mumbai
About The Company
Shalina Healthcare is a prominent pharmaceutical organization committed to delivering high-quality healthcare solutions across diverse global markets. The company operates multiple manufacturing units and testing facilities, focusing on a broad range of formulations, including OSD (Oral Solid Dosage), Sterile, Oral Liquids, and External products. With a strong emphasis on GMP, GLP, and GDP compliance, Shalina Laboratories maintains a robust Quality Management System (QMS) to ensure audit readiness and operational excellence at all Shalina operating units (OUs).
Responsibilities of the Pharmacy Job
- Preparation and adherence to the annual planner for Quality audits for Loan Licence Units (LLU), Third Party Manufacturing, Sites to conduct periodic due diligence & for cause quality audits to ensure GMP compliance and to monitor overall performance of the manufacturing.
- Preparation and adherence to the annual planner for Quality audits for public testing laboratories to conduct periodic, due diligence & for-cause quality audits to ensure GLP compliance and to monitor overall performance of the testing facility.
- Preparation and adherence to the annual planner for Quality audits for Shalina Operating units (OUs) to conduct periodic, due diligence & for-cause quality audits to ensure GDP compliance.
- Planning of audits as per the approved audit planner, Review of audit outcome, preparation of audit reports, and coordination with vendors for compliance within the timeframe.
- Review of audit compliance report for any external/regulatory/customer audits received from the location, and to monitor closure of individual observations by reviewing relevant supporting data.
- To initiate the actions based on audit findings and compliance reviewed from the location for approval, rejection, and conditional approval of the manufacturing/testing facility.
- To conduct self-inspections of individual departments, compile of report, track, and review of compliance for timely closure.
- To ensure the all-time audit readiness of Shalina Laboratories sites.
- Coordination for compilation and review of technical documents received from vendors for evaluation and arranging analysis of samples, comparative evaluation of results and maintaining all the technical records for each vendor as per SOP.
- Introduction, implementation, and effectiveness checks for the Quality Management System (QMS) to all Shalina manufacturing sites.
- Preparation for presentation of the monthly quality review meeting (QRM) to present overall status of the section and to highlight any open issues that were not resolved within the timeline.
- Coordination, tracking and monitoring of all QMS, Vendor Management and documentation-related activities in the absence of a designee from the respective section, if required.
- To conduct training at periodic intervals on important quality aspects and to get awareness and updates on current guidelines and GMP requirements.
- To support other cross-functional teams for any technical inputs for implementation and maintaining the quality system of Shalina laboratories Private Ltd.
- Any other specific work assigned by Global Head – Quality.
Required Skills & Experience
- Qualification: B. Pharmacy or M. Pharmacy or any science graduate with relevant experience.
- Thorough Knowledge of the shop floor of OSD, External, Oral Liquid & Sterile formulations, Handling of contract manufacturing Sites.
Competencies
- The candidate should have good exposure to GMP environment and regulatory inspections for the quality assurance job.
- Candidate should be flexible for business travelling across India & Overseas Locations.
- Candidates working on Shop floor and should have good GMP/GLP exposure.
- Independent and candidates who are able to make decisions online.
- Cross functional working and good ability to communicate with external stakeholders.
