Quality Assurance Specialist

Sekem -
Salam City, CairoPosted 5 years ago

207Applicants for1 open position

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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.

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