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QA Validation Senior Specialist ...

Ptcell
10th of Ramadan City, Sharqia

QA Validation Senior Specialist - Pharmaceutical

Ptcell
10th of Ramadan City, Sharqia
Posted 20 days ago
48Applicants for1 open position
  • 22Viewed
  • 1In Consideration
  • 33Not Selected

Job Details

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Job Description

1. Actively be involved in the execution of all stages of the validation life-cycle
2. Prepare the validation master plan.
3. Prepare, update and execute the Validation, Calibration & Qualification SOPs 
4. Prepare, update and execute the Validation and Qualification plans. 
5. Prepare and execute the Qualification Protocol (IQ, OQ & PQ).
6. Prepare all Validation and Qualification reports.
7. Prepare and execute the CSV URS and protocols (DQ,IQ, OQ & PQ).
8. Notify the Compliance team Leader of any issues which may impact the client (quality issues, validation completion deadlines).
9. Ensure that all validation activities and documentation are complying with the recommendations of relevant products technical master files.
10. Represent Validation on project teams to ensure that validation tasks are identified, planned, monitored and completed in a timely manner.
11. Reviewing of the External Calibration and Qualification certificates, Protocols and reports.
12. Participate in Deviations (if needed)
13. Participate in Change control (if needed)
14. Participate in risk assessment (if needed)
15. Participate in customer complaint (if needed)
16. Participate in internal and external audit (if needed)

Job Requirements

  • Bsc Science or Pharmacy is a must.
  • minimum 3 years' experience.
  • Knowledge of GMP & ISO 9001 is a plus.

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