QA Specialist - Sharqia

Sekem - Belbes, Sharqia

27
Applicants for
1 open position
3
Seen
Experience Needed:
2 to 3 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential
Vacancies:
1 open position
About the Job
  • 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.
About this Company

SEKEM was founded with the idea of sustainable development and giving back to the community. The vision that brought Dr. Ibrahim Abouleish to dig the first well in the vast desert land still resounds in SEKEM’s approach of conducting business. Like a compass, our vision,... (More)

See all Careers and Jobs at Sekem
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