Leadership Hiring Specialist at Randstad India Private Limited
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Corporate Quality Manager - Pharma - B.Pharma (8-10 yrs)
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
- 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.