Job as a API DQA Expert at Dr. Reddy's Laboratories

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Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

Post: API DQA Expert

Job Description:
• Ensure proper guidance on quality issues to the Product Development Teams
• Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers
• Review the process change proposals and help the team members provide guidance on change proposals
• Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members
• Ensure proper stage gate compliance at various stages of product development
• Ensure that internal audits are conducted properly
• Review the developmental reports and other documents
• Ensure appropriate qualification of CRO (clinical research organization/contract research organization)
• Ensure appropriate qualification of external manufacturing sites
• Ensure self inspection programs are conducted properly across IPDO
• Review the existing GMPs, STPs, GLPs or SOPs and update them if required
• Help the team members manage change controls, deviations, incidents
• Ensure international customer’s audits, regulatory audits, etc. is handled in a suitable manner
• Ensure proper maintenance of central documentation, i.e. the Development Quality Assurance (DQA) document cell
• Support audits/ quality investigations issues of other Business units
• Ensure thorough Inspection of quality till the exhibit batch stage
• Ensure quality by design, i.e. ensure robustness of product and process

Candidate Profile:
• Required Education: M.Pharm/PhD
• Minimum Experience:
10 – 15 years experience as DQA/CQA in research environment
• Skills:
Working experience in QbD and other new ICH, FDA guidelines

Additional Information:
Location: Hyderabad

Exp: 10-15 Years
Education: Ph.D, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, QC

Last Date: 31st July, 2011

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