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Job for Quality Assurance Manager at Roche

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Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

Post : Manager - Quality Assurance

Job Purpose
• Manages all requirements related to management of Quality system requirements for Roche India.
• Implement directives issued by Global Technical team and adhere to maintain GMP, GDP and GSP compliant Quality systems.
• Achieve and sustain the state of compliance to ensure deliverance of quality products to the customer.

Key Accountabilities:
List the expected end results that must be achieved in order to fulfil the job purpose and the activities that help in achieving these results.
1. Ensure Implementation of Global Procedures related to Quality Aspects at India Affiliate
2. Ensure cGMP/GDP/GSP followed at india Affiliate level by conducting Audits/visits at Warehouse , CFA & Redressing sites in India.
3. Conduct Trainings for on cGMP/GDP/GSP.
4.  Accountable for the design, development, deployment monitoring, governance and continual improvement of the Transportation Quality (TQ) & Distribution Quality (DQ) part of the Roche Pharmaceutical Quality System (PQS) based on international / national regulatory requirements and industry best practices and guidance documents.  The area of responsibility includes the storage, shipping, transportation, transport validation and controlled temperature handling of supply chain materials.
5. Release of Imported products at India Market for further sale and distribution.
6. Recall, Counterfeit, Complaint, Change control & Discrepancy Management.
7.  Review and approval of Quality Agreements and ensure the compliance of the same.

Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 30th July, 2019


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