Officer - Quality Assurance

PeopleStrong; India; On-site; INR 400,000 - 700,000; Full time

Job summary

PeopleStrong in India is seeking an IPQA/QC professional to ensure line clearance at dispensing, manufacturing and packing stages, perform online in-process activities per BMRs/BPRs, and report deviations to a supervisor.

You will collect and send samples, participate in process validation and qualification activities, verify batch documents, calibrate IPQA instruments, monitor CAPA effectiveness, and ensure cGMP, GDP and GEP compliance during your shift.

Qualifications

• Experience in IPQA activities in pharma manufacturing.
• Familiarity with BMRs/BPRs and change control.
• Strong understanding of cGMP, GDP and GEP.

Responsibilities

• To give line clearance at dispensing, manufacturing and packing stages.
• To perform online in-process activities during manufacturing and packing area per approved BMRs & BPRs and report deviations to supervisor.
• To collect and send samples for routine batch analysis from respective stage, retest samples, hold time study and cleaning validation samples.
• Execution of process validation activities per approved validation protocol.
• Assist qualification activities per respective protocol/instructions.
• To collect and hand over samples in control sample room.
• Submission of stability samples with stability requests in QC department.
• Ensure cGMP, GDP and GEP compliances during shift in respective area.
• Review batch documents online at each stage and completion of batch.
• Verify verifications/calibrations of IPQA instruments daily, monthly and quarterly.
• Monitor effectiveness of CAPA taken relevant to shop floor.
• Verify rejected consignments at warehouse.
• Issue documents like BMRs, BPRs pages in shift per requirements.
• Perform any other task assigned by section in-charge.

Skills

IPQA processes

QA documentation

GMP awareness

Tools

LIMS

Job description

1. To give line clearance at relevant stages of process i.e. dispensing, manufacturing and packing stages.

2. To perform online in-process activities during manufacturing and packing area as per approved BMRs & BPRs and immediately reporting of any deviation to supervisor.

3. To collect and send samples (through LIMS/manually) i.e. routine batches analysis samples from respective stage, retest samples, process, Hold time study and cleaning validation sample as per respective sampling plan to quality control unit.

4. Execution of the process validation activities as per approved validation protocol.

5. To assist qualification activities as per respective protocol/instructions.

6. To collect and handed over the sample in control sample room.

7. Collection & submission of stability samples with stability request in QC department.

8. To ensure cGMP, GDP and GEP compliances during his shift in his respective area.

9. To review batch documents i.e. BMRs and BPRs online at each stage and completion of batch.

10. To perform daily, monthly and quarterly and/or as per requirement, verification/ calibration of respective IPQA instruments.

11. To monitor the effectiveness of CAPA taken relevant shop floor.

12. To verify the rejected consignment at warehouse.

13. To issue documents i.e. additional pages of BMRs, BPRs in shift as per requirements.

14. To perform the any other task/responsibility assigned by section in-charge.