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QA Specialist - Sharqia

Sekem
Belbes, Sharqia
Posted 4 years ago
63Applicants for1 open position
  • 3Viewed
  • 0In Consideration
  • 0Not Selected
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Job Details

Experience Needed:
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Skills And Tools:

Job Description

  • Support operations becoming familiar with site processes, procedures, and policies assuring alignment with cGMP and Health Authority regulations.
  • Conducts batch record reviews, audits, investigations, and internal audits/external inspections.
  • Supports sampling requirements for several areas.
  • Performs quarantine functions and accountability reviews.
  • Supports special projects as assigned.
  • Follow cGMP and routinely makes decisions using cGMP/process knowledge.
  • Works with customers to resolve problems and to satisfy quality and production needs.
  • Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance.
  • Follows site safety requirements.
  • Authors and reviews data and documents such as methods, procedures, and protocols.
  • Performs activities associated with Equipment IQ, OQ, PQ's and Calibrations, Validation Protocols, and Reports.
  • Writes Validation Protocols and Reports.
  • Support Equipment Qualifications and Calibrations.
  • Plan and coordinate cleaning, manufacturing processes, facilities and equipment validation activities.
  • Support cleaning evaluations and verification.
  • Develop validation plans and schedules.
  • Coordinate validation activities with heads of departments.
  • Awareness with ISO 9001, 14001, OHSAS 18001.

Job Requirements

Qualifications:

  • B. Pharmaceutical. or B.Sc.
  • 2 – 3 years of experience in the pharmaceutical industry.

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