FULLTIME
Officer - IPQA
USV
Not specified · onsite · Posted 8d ago
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Section · 01
About this role
- Line Clearance:–To give the line clearance for the different activity in their concern area like Dispensing, Granulation, Blending, Compression, Capsule, Coating and Packing as per their respective SOPs and batch records.
- Monitoring & Verifying of Records: – To monitor day to day activity in all area like Days store, Change part room, Quarantine area and Accessory room. Verifying the logbook, environment monitoring record, inward outward record and inventory records of all concern areas.
- In-process Activities: – Perform the in process activities as per the SOPs, BMR and BPR in all concern areas like Compression, Capsule and Packing.
- Sampling: – Doing the sampling at different stages like Blending, Compression, Coating, Capsule and Packing as per the SOPs, BMR and sampling plan.
- Process Validation activities: – Monitoring of the validation batch at different stages and collection of samples as per the protocol.
- Documentation & Calibration: - Maintaining the all documents related to the IPQA like Semi finish sample register, Validation sample register, Rinse water register, control sample register, finish sample register and performing the calibration of the equipment in IPQA.
- Document review: - Review the documents like BMR and BPR checking the compliance & reconciliation of the products after the completion of respective stages.
- Analysis of Semi finish and testing of PVC/PVDC: - Perform the analysis of semi finish sample of coated tablet of some of products and give there released for the next stage and confirm the PVDC /PVC orientation by Morpholine test.
- Co-ordination with stakeholder: - In day to day activities, do the coordination and communication with Production, warehouse, QC and Engineering for the in time activity and compliance.
- APQR Data entry: - To make online data entry of every product/batch into format of APQR in softcopy.
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Section · 02
Skills
Analysis of Semi finish and testing of PVC PVDCAPQR Data entryDocumentation CalibrationIn-process Activitiesprocess validationDocument ReviewSamplingline clearance
Section · Company
About USV
USV
Pharma
7.1k+
employees
1961
65 years old
Mumbai, Maharashtra
India
About
USV India is the top old leading healthcare industry & pharmaceutical company in Mumbai, India. They provide API, Peptides, Biosimilars, Injectables, Ophthalmics & Solid Orals products in India
Industries
PharmaManufacturing
Employee ratings
1,753 reviews
4.0/ 5
Culture
3.8
Career growth
3.5
Work-life
3.8
Employees rate it well for
Work Culture220Salary137Senior Management115Work Environment110Appraisal91
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