executive

Lupin

Panaji

On-site

INR 600,000 - 1,100,000

Full time

4 days ago
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Job summary

Lupin in India is seeking a QA/IPQC professional with 4–6 years of experience to manage in-process and finished product sampling, hold time studies, and rigorous documentation in a GMP environment.

You will review log books, environmental monitoring, and equipment usage, ensuring line clearances and PAS-X document workflows are correctly executed and released.

Qualifications

  • 4–6 years of work experience in QA/IPQC in pharma manufacturing.
  • Experience in handling batch records, BRRs, ESPs and cleaning validation.
  • Strong documentation and instrument maintenance skills.

Responsibilities

  • In-process sampling and testing.
  • Finished product sampling (bulk finish and packed samples).
  • Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
  • Perform QA to note deviations from SOPs and record observations.
  • Maintain instruments in IPQC and routine calibration.
  • Review log books and environmental monitoring files.
  • Review equipment usage, cleaning records, area usage, balance calibration, etc.
  • Issue line clearances for activities in Production.
  • Execute, review and release/approve documents like BRRs and ESPs in PAS-X.
  • Execute, review and approve batch manufacturing and batch packing records.
  • Participate in equipment qualifications as required.
  • Execute cleaning validation and equipment qualification.

Skills

IPQC testing
Quality Assurance
Calibration
Environmental Monitoring
Documentation Review
Equipment Qualification

Education

Graduation in Pharmacy
Post Graduation in Pharmacy

Tools

PAS-X System

Job description

Job Description:


Job Description


  1. In-process sampling and testing.

  2. Finished product sampling (Bulk finish and Packed samples).

  3. Hold time study execution and sampling at hold time stage, bulk finished and packed samples.

  4. Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.

  5. Maintenance of instruments in the IPQC & routine calibration.

  6. Review log books and environmental monitoring files.

  7. Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.

  8. Line clearances for different activities in the Production Department.

  9. Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.

  10. Execution, Review and Approval of batch manufacturing records and Batch Packing records.

  11. Participate in equipment qualifications as per the requirements.

  12. Execution of cleaning validation & equipment qualification.


Work Experience

4 to 6 years


Education


  • Graduation in Pharmacy

  • Post Graduation in Pharmacy

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