Preparation and adherence to 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 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 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 approved audit planner, Review of audit outcome and preparation of audit reports and co-ordination with vendors for compliance within timeframe.
Review of audit compliance report for any external/regulatory/customer audits received from location and to monitor closure of individual observations by reviewing relevant supporting data.
To initiate the actions based on audit findings and compliances reviewed from location for approval, rejection and conditional approval of the manufacturing/testing facility.
To conduct self-inspections of individual departments, Compilation of report, tracking and review of compliance for timely closure.
To ensure the all-time audit readiness of Shalina laboratories sites.
Co-ordination 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 Quality management system (QMS) to all Shalina manufacturing site.
Preparation for presentation of monthly quality review meeting (QRM) to present overall status of the section and to highlight any open issues which was not resolved within timeline.
Co-ordination, tracking and monitoring of all QMS, Vendor Management and documentation related activities in absence of designee from respective section, if required.
To conduct the 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 quality system of Shalina laboratories Private Ltd.
Any other specific work assigned by Global Head - Quality.
Required Skills & Experience
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:
Candidate should have good exposure to GMP environment and regulatory inspections.
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 able make to decisions online.
Cross functional working and good ability to communicate with external stakeholders.
