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 : 8 to 10 years

- Minimum 8-10 years in Pharma industry of which minimum 2-3 years in Contract Manufacturing and QA.

- Knowledge of Performing GMP & 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 & 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 & 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 & cost with the contract manufacturer along with Head Quality South Asia & Procurement.

- Packaging material artwork review, approval & implementation at site.

- Maintenance & 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 & GMP.

- Provide required explanation or implement corrective action for ensuring yield & consumption variance are within defined limits for the assigned manufacturing site.

- Quality Assurance (for the assigned manufacturing sites & Warehouses)

- Perform GMP/GDP audits at contractors/CFAs/Input material vendors / new opportunities to ensure GMP, Regulatory & Safety compliance at these sites.

- Support Cluster Quality Head - South Asia (AH, PH, CH) for India, Nepal, Bangladesh, Srilanka & 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) & 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 & 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 & 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 & interaction on customer complaints and queries with customers.

- Perform assessment of new vendor/ Service provider requests & 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 & 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 & CH).

- Liaising with Indian Pharmacopoeia commission for inclusion, amendment of monographs in Indian Pharmacopoeia (IP).

- Primary contact for agencies regarding quality related issues & 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 & support function, Regional Sites Co-ordination in qualification of global suppliers.

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