Opportunity to work for a Pharma MNC. Destination : Quality Manager Locations : Mumbai Reporting to : Head Quality Minimum Education : Bachelor of Pharmacy (B. Pharma), Masters degree preferred but not mandatory Experience : - Total : 10 to 18 years - Minimum 8-10 years in Pharma industry of which minimum 2-3 years in Contract Manufacturing and QA. - Knowledge of Performing GMP &amp; GDP Audits is beneficial. - Specific Computer literacy skill essential like Word, Excel, PowerPoint etc. Job Description : POSITION PURPOSE : - This position will primarily be responsible for supporting the Head Quality South Asia in fulfilling his responsibilities which includes helping the company to meet its Business objectives by supporting it 3 divisions in activities pertaining to areas of : - Local Quality Management System and compliant Quality process execution of assigned manufacturing sites. - Quality Overview on Supply Chain &amp; Logistics of assigned CFAs - Assigned Projects or initiatives - Assigned new products - Handling of IT tools like BASICS, Dev@com, AIDa, SCORE, CLMS for implementing Local Quality Management System WHAT YOU DO : - Manufacturing &amp; Supply (for the assigned manufacturing sites) - Act as the company's Quality representative while dealing with management of contract manufacturer. - Ensure un-interrupted Supply of Finished Goods meeting quality standards. - Shooting the trouble at Contract Manufacturing sites related to Technical and Quality aspects. - Participate in negotiation of commercial agreement &amp; cost with the contract manufacturer along with Head Quality South Asia &amp; Procurement. - Packaging material artwork review, approval &amp; implementation at site. - Maintenance &amp; upkeep of change parts inventory at contract manufacturing locations - Adhere to the directives and the guidelines issued by the company's AG and statutory authorities pertaining to manufacturing site on SHEQ &amp; GMP. - Provide required explanation or implement corrective action for ensuring yield &amp; consumption variance are within defined limits for the assigned manufacturing site. - Quality Assurance (for the assigned manufacturing sites &amp; Warehouses) - Perform GMP/GDP audits at contractors/CFAs/Input material vendors / new opportunities to ensure GMP, Regulatory &amp; Safety compliance at these sites. - Support Cluster Quality Head - South Asia (AH, PH, CH) for India, Nepal, Bangladesh, Srilanka &amp; Pakistan. - Negotiate and execute the terms of quality agreement with the Vendors. Maintain all Quality Agreement in valid state. - Ensures Quality Oversight and compliance on to the Distribution function on All India basis. - Ensure mandatory compendial / Pharmacopoeia compliance of input materials and finished products. - Perform quality checks through random Sampling and analysis of the samples with the help of approved contract laboratory - Review of APR (Annual product review), PVP (Process Validation Protocol) &amp; PVR (Process validation report), Analytical method validation / transfer, BMR (Batch Manufacturing Records), Market complaints investigations, COA (Certificate of analysis), Stability reports, OOS, change control, Deviation and ensure implementation of CAPA at CMO site. - Perform Technology Transfer - To organize and execute the analytical method validation / transfers, process validation of various dosage forms like tablets, external preparations, liquids and parenteral preparations. - Maintain &amp; update databases like AIDa, Dev@com, BASICS, SCORE and CLMS for implementing Local Quality Management System. - Prepare and maintain Quality Assurance documentation like SOPs (Standard Operating Procedures), Input materials and finished products specifications &amp; testing procedures, MFR (Master Formula Records), Deviation, Change control, Market complaints, investigations and CAPA under QMS at the company wherever applicable the aforesaid IT tools will be used. - To educate and update the manufacturing sites on GMP and the company quality requirements. - Review and check applicability of global directives and wherever required write local SOPs and Quality Assurance documentation (SOPs, technical dossiers). - Handling &amp; interaction on customer complaints and queries with customers. - Perform assessment of new vendor/ Service provider requests &amp; qualify the same. - Seek Global QA approval for Repackaging operations prescribed under the Directives. - Regulatory (for the assigned manufacturing sites) - Review and approve printed packaging material artworks - Coordination for implementation of Pharmacopoeial changes with CMOs. - Management of reference &amp; working standard required for product testing at CMOs and external labs etc for Animal Health (AH) and coordination with CMOs to provide working standards to external labs for Pharma (PH &amp; CH). - Liaising with Indian Pharmacopoeia commission for inclusion, amendment of monographs in Indian Pharmacopoeia (IP). - Primary contact for agencies regarding quality related issues &amp; provides local support for Health authority inspections and representation. Assigned Projects or initiatives : - Perform the assigned task (Product and Manufacturing site evaluation) related to new product introduction in agreed time frame. - Seek approval from respective Global stake holders. - Participate in audits of the company's AG Audit &amp; support function, Regional Sites Co-ordination in qualification of global suppliers.

Mumbai

Manager - Quality - Pharma 

Manager - Quality - Pharma  ,Job Description for Manager - Quality - Pharma  in Randstad India Private Limited in  Mumbai for (10-18) years of experience. Apply Now!

Job Description for Manager - Quality - Pharma  in Randstad India Private Limited in  Mumbai for (10-18) years of experience. Apply Now!