Executive - Quality Assurance (IPQA)

Roles and Responsibilites

1.In process Quality Assurance activity in Production and warehouse area
2.Provide line clearance as per SOP
3.Monitoring and QA rounds in production and Warehouse
4.Sample verification against TRF / BPCR
5.Carry out Semi-finished / finished product sampling for release, stability study and control samples
6.To send samples along with TRF to Quality control laboratory
7.Participate in media fill, process validation, cleaning validation activities as per requirement
8.Timely communication and co-ordination with all the stake holders
9.Participation in Change control, Deviation & Investigations as per requirement
10.Preparation / review of documents like; SOPs, risk assessment report and any other document as per requirement
11.Timely review of Batch Process & Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data
12.Timely review of executed batch records and associated data
13.Keep vigilance on production operations
14.Review of Analytical Reports as per requirements
15.Participation in Audits & Compliance activity
16.In addition of above, any other responsibility assigned by Superior / HOD
17.Final release of critical intermediate and drug substance batches in LIMS and SAP
18.Risk assessment preparation and review
19.Draft MFR/BPCR/BPR review

Qualification Required

B. Pharm / M. Pharm

Relevant skills / Industry experience

2-7 Years with Injectables or Biotech Induastry in IPQA department