Pharmaceutical Quality Assurance (3-5 Years)

Key Skills

Quality Assurance Executive Pharma Quality

Job Description

We have an urgent opening for Quality Assurance Executive for a leading Chemicals Mfg Company

Job Profile: Quality Assurance Executive

Location: Ankleshwar

Salary Range Approx- 4-5LPA

Experience - 4 or 5 years only pharma line (API experience )

REPORTING TO : Head QA

RESPONSIBILITIES:

1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material.

2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs.

3. During plant round QA Executive to verify documents as per cGMP and GLP norms.

4. Line Clearance activities for manufacturing and packaging before process starts.

5. To issue the deviation form, Change control form, Out of Specification form, Customer complaint form, OOT form, investigation for etc. as per request from respective dept.

6. Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA verification and release of finish product.

7. To prepared documents & records and monitoring of activities as per SOPs

8. Distribution, retrieval and control of SOPs, documents/records of all dept.

9. To participate the internal audits, customer audit, regulatory inspection.

10. To Attend QR meeting as per schedule.

11. To ensure data integrity as per procedure.

12. To review manufacturing, store, QC activity.

13. To prepare approved vendor list and maintain vendor qualification.

14. Conduct traceability Activity.

15. Preparation and maintain CAPA log.

16. To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.

17. To collect data and prepare the annual product review.

18. To witness and verify process validation, cleaning validation and equipment qualification and to prepare protocol and report.

19. Returned Material: Investigate and make
  • Experience

    3 - 5 Years

  • No. of Openings

    2

  • Education

    B.Sc, M.Sc

  • Role

    Pharmaceutical Quality Assurance

  • Industry Type

    Pharma / BioTech / Clinical Research

  • Gender

    Male

  • Job Country

    India

  • Type of Job

    Full Time

  • Work Location Type

    Work from Office

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