Job as a API DQA Expert at Dr. Reddy's Laboratories
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
To apply Click Here
You may also share your profile at the following email address:
noelr@drreddys.com
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