About the Company :
The firm located in Mumbai and is distributed across 110 countries across the globe with 6500 colleagues working for the company. The company focus on advanced injectables and especially in reproductive medicines like urology and gastroenterology division. The firm is a research driven providing quality medicine.
About the Job :
Experience : M. pharma/B. pharma with 10-12 years of experience in QA/QC/Manufacturing in cGMP area with a quality role
Responsibilities for the Job :
- Able to Handling Quality activities in ERP – Navision
- Should be Handling Quality activities in ERP – Navision
- Thorough knowledge on Customer management in Track Wise
- Candidate should Review of analytical raw data for raw materials, Drug substance, Packing materials, including CoAs, specifications and MOA.
- Able to Manage intermediate and bulk batch review, including all test requirements and Certificate of Analysis program, and perform disposition and Implementation of ERP – Navision
- Perform or oversee operational investigations and material hold process.
- Agile in Support process validation and technology transfer activities, including creation and review of associated batch documentation.
- Able to Establish QMS metrics, segmentation and provide trend information for management review.
- Need to draw the Self-Inspection – Plan and Execution
- For the role Quality Assurance in Supply Chain (GDP): Monitoring GDP and releases for products distribution.
- Establish and maintain the Document, Deviation Management, Change Management and Training Program
- Available to monitor batch manufacturing procedure as per MFR and GMP
- Manage training program (Matrix and LMS Training)
- Manage the Document Request, Deviation management, Change Control systems in Track Wise, and provide guidance on processes.
- Manage all record filing, retention and retrieval, including any off-site storage.
- Provide direct support to manufacturing of products and documentation:
- Support creation of MBRs, BMR/BPR, specifications, COAs, and release criteria.
- Manage batch record review, including CMO records, all test requirements and Certificate of Analysis program, and perform disposition.
- Should Ensure Quality oversight and control on Third Party Manufacturing sites and dispositioned products, in conjunction with Manufacturing, Technical Services
- Preparation of SOPs, Trainings.
- Able to Execute Mock Recalls with distribution, prepare Protocol and Report.
- Handle the Quality Compliance within Supply Chain Operations including Temperature Monitoring in Warehousing and Transportation,
- Audit Preparedness and compliance to Local and CSOPs.
- Require to Support for Self-Inspection, Customer Management:
- knowledge on Compliance to SOPs, Quality Audits & Closure of CAPA in Track Wise.
- experience to Conduct GDP audits of Warehouses and CFAs / Stockiest
Send resumes to the below