At 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.
Roche Diagnostics India, with a sales turnover of INR 150 crores, nurtures an open, flexible and challenging work environment, which allows for rapid career progression. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland — a great place to live and work.
Post: Manager - Quality Assurance
Job Description
This position will lead and be responsible for management of Quality Assurance (QA) function and will report to Associate Director – Regulatory Affairs & Quality Assurance
- You will be responsible for ensuring good distribution practices as is laid down in the guidelines of India and as per Roche Global standards are followed while the products are stored and distributed to the customer
- You will prepare SOPs in line with Global Quality guidelines, Product Quality Systems(PQS) and ensure its implementation
- You will prepare and execute quality agreements with third parties and service providers and revise agreements based on changes to global quality guidelines, if required
- You will ensure all quality checks are performed as per procedural documents before release is provided for the imported shipments, as well as when the batches are transferred from warehouse to Clearing & Forwarding Agents (CFA's)
- You will initiate and review change control records for performing impact assessment and risk assessment of changes to a unit impacting product quality, document and investigate discrepancies and plan and execute internal QA audits
- You will review batch packaging record (BPR) for redressing (relabeling/ stickering/ stamping) activity for shipments and will also review price change or other activities in line with health authority requirements
Candidate Profile
- You are a Post Graduate with 8 – 10 years of experience in Quality Assurance
- You have knowledge of good distribution and good manufacturing practices
- You have knowledge of statutory requirements for distribution of products
- You have set high standards of performance for self and others and take responsibility and accountability for successfully completing assignments or tasks
- You have proven track record of leading teams and driving collaboration
Additional Information:
Job ID: 2976651115
Location: Mumbai- Maharashtra
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Quality & Compliance
End Date: 25th Feb., 2017
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