Officer - Quality assurance (Biotech)

Officer - Quality assurance (Biotech)

JD -
1) Review of the documents for production activity, Review of BPR, Protocol, SOP and
Equipment Qualification Protocols and Final reports and Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment
2) Knowledge regarding shopfloor activities like line clearance, sampling and in-process checks
3) Having knowledge of QMS activity like Deviation, CAPA, Change control.
4) Experience in In-process activities for drug product in Biotech / Pharmaceutical sterile facility.

Education - MSc, B Pharm, M Pharm

Total Experience - 2 - 5 Years.