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Aurobindo Pharma Ltd. is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$650Mn, with presence in more than 22 countries across the globe.
Job Title : Formulation Analytical Research – DQA
Experience : 4 – 6 Years
Location : Hyderabad
Qualification : MS/M.Sc(Science) – Bio-Chemistry, Biotechnology, Microbiology, Organic Chemistry, Pharmacy
Job Description
- Must have strong theoretical knowledge in chromatography, spectrophotometry and inhalation analytical technique.
- Experience of working in cGMP labs.
- Review of analytical method verification/validation protocols and reports.
- Review of calibration and qualification documents.
- Aware of regulatory requirements, current ICH and pharmacopeia updates.
- Execute internal audit and monitor the cGMP practices in lab on routine basis.
- Actively participate in regulatory inspections.
- Investigate abnormal results and discuss them with group leader.
- Issuance and maintenance of logbook, LNBs, register, worksheet etc.
- Initiation and investigation of incidents, deviations and out of specification results.
- Maintain all the training records and coordinate to train the new associate.
- Prepare new SOPs/guideline on demand and monitor the review dates.