Officer - IPQA

PeopleStrong; Himachal Pradesh; On-site; INR 400,000 - 600,000; Full time

Job summary

PeopleStrong is seeking IPQA/QC focused personnel in Himachal Pradesh to oversee line clearance, record monitoring, in-process activities, and sampling across multiple pharma manufacturing stages. The role includes process validation oversight, PVDC/PVC testing orientation verification, and meticulous document review and calibration of equipment.

You will coordinate with Production, Warehouse, QC and Engineering to ensure timely, compliant execution and contribute to APQR data entry for each

Qualifications

• Line clearance for multiple activities per SOPs and batch records.
• Monitor and verify records including logs, inventory, and environment monitoring.
• Carry out in-process activities per SOPs, BMR/BPR.
• Sampling at stages per SOPs and sampling plan.
• Monitor process validation activities and collect protocol samples.
• Maintain IPQA documents and calibrate equipment.
• Review BMR/BPR for compliance and reconciliation after stages.
• Analyze semi-finish samples and PVDC/PVC orientation testing (Morpholine test).
• Coordinate with Production, Warehouse, QC and Engineering for timely activities.
• APQR data entry into softcopy formats.
• Assess breakdowns.

Responsibilities

• Perform line clearance for Dispensing, Granulation, Blending, Compression, Capsule, Coating and Packing as per SOPs and batch records.
• Monitor and verify records across all IPQA areas including stores and quarantine.
• Execute in-process activities in Compression, Capsule and Packing per SOPs, BMR and BPR.
• Conduct sampling at various stages according to the sampling plan and SOPs.
• Oversee process validation activities and collect samples per protocol.
• Maintain comprehensive IPQA documentation and ensure calibration of equipment.
• Review BMR and BPR to ensure compliance and reconciliation of products at each stage.
• Analyze semi-finish samples and PVDC/PVC testing using Morpholine methods.
• Coordinate daily with Production, Warehouse, QC and Engineering for timely execution and compliance.
• Enter APQR data online for each product/batch.

Skills

Line clearance

Monitoring records

In-process

Sampling

Process validation

Documentation

Calibration

Document review

PVDC testing

Coordination

APQR data entry

Job description

• 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.

Assessment of Breakdowns: - To perform the assessment of breakdowns.