Quality Assurance Specialist
Sekem -
Salam City, CairoPosted 5 years ago207Applicants for1 open position
- 37Viewed
- 0In Consideration
- 0Not Selected
Job Details
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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 verifications.
- Develop validation plans and schedules.
- Coordinate validation activities with heads of departments.
Job Requirements
- Bachelor’s degree in the related field
- Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
- Relevant long-term experience, knowledge of regulatory requirements
- The knack for implementation of corrective action programs
- Experience in the related industry or with related products
- Superb computer competence, including experience with databases and Microsoft Office
- Knowledge of QA terms, tools, and methodologies
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