Our Hyderabad-based pharma Client started about 20 years ago as predominantly an API player, but, has, over years, morphed into a predominant formulations player; API-to-formulations changed 43%-to-57% in FY11 to 20%-to-80% now. It operates 22 manufacturing facilities, including 8 formulations facilities in India and abroad; owns 3 R&D centres; current employee strength is - 8000, including - 750 scientists.   Company has been very aggressive in maintaining a very healthy pipeline of ANDAs; they have been able to pick right product mix to improve top & bottom line growth. The Organization is extremely dynamic and expects its leadership team in every function to measure up to this dynamism through their speed of response, quality and effectiveness of performance.  Client is hiring a GM QC for one of their prestigious Injectable Units  Purpose of the role  - Accountable for all QC function at the site  Strategic Roles  - Work in tandem with Manufacturing, procurement, Regulatory, R & D etc for ensuring quality and compliance  - Work with Plant QA and Corporate QA to nsure that quality serves as a clear differentiator and a distinct advantage to Organization  Compliance with QMS  - Ensure compliance to written procedures in routine quality control operation  - Review change controls pertaining to QC function and ensure risk assessment are performed   Improvements to QMS  - Propose new quality systems to improve the quality parameters and overall improvement in methods  - Improve existing prediction methods   - Find new approaches to measure quality attributes  Laboratory  - Ensure agreed service levels on analyses are met consistently   - Perform periodic gap analysis and implement improvements on laboratory compliance  - Review specifications, standard test procedures, protocols, analyst qualification and analytical method validation documents and ensure compliance  - Investigate laboratory incidents (out-of-specification, out-of-trend and such) and deviations and ensure appropriate timely implementation of CAPAs   - Comply with aspects of calibration, preventive & breakdown maintenance of lab instruments and equipment  - Implement documented testing methods  Inspection  - Implement documented procedures for release or rejection of incoming, in-process of FG   Training  - Provide initial and additional training to QC staff in regard to GMP, Good Lab Practices, QMS, Regulatory, Audits etc  Regulatory Audits  - Prepare for and go through regulatory and customer audits of site  - Audit facility for compliance  OpEx control  - Control Operating Expenses  Customer Connect  - Investigate customer complaints

Hyderabad

General Manager - Plant Quality Control - Injectable Units - Pharma  

General Manager - Plant Quality Control - Injectable Units - Pharma   ,Job Description for General Manager - Plant Quality Control - Injectable Units - Pharma   in TMI Network in  Hyderabad for (18-20) years of experience. Apply Now!

Job Description for General Manager - Plant Quality Control - Injectable Units - Pharma   in TMI Network in  Hyderabad for (18-20) years of experience. Apply Now!