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Quality Assurance Qualification and Validation Supervisor

2 days ago 2024/06/23
5-9 years of experience

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Job Description

  • Initiate and execute validation studies throughout the facility.
  • Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects.
  • Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.
  • Identify necessary internal and external resources for completion of validation projects and secure the necessary support (Production, QC, and QA, outside contractors).
  • Interface extensively with the QC/QA, Production and engineering departments to identify projects and problems requiring validation support.
  • Plan and manage priorities to ensure critical projects meet required deadlines.
  • Develop and implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes.
  • prepare the protocols for process validation, hold time study, campaign length cleaning validation, IQ/OQ and performance qualification.
  • Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance.
  • Follow up overall qualification/validation activities include (HVAC, thermal mapping, machine qualification, laboratory instrument qualification, etc….).
  • Ensure appropriate testing with quality control and support methods validation with R&D department is completed.
  • Review and analyse moderately complex analytical and physical data generated from validation activities.
  • Write validation final reports that present, summarize conclusions on the validity of the process based on the results of the analysis.
  • Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results and assisting production in resolving any identified problems
  • Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities,
  • Ensure critical deadlines are met for complex projects with quality assurance manager supervision.



Skills

  • Bachelor of pharmacy or science
  • (5-9) year of experience
  • Computer knowledge of Microsoft excel, word as well as soft skills
  • Good English language skills


Job Details

Job Location
Cairo Egypt
Company Industry
Laboratory & Quality Control
Company Type
Employer (Private Sector)
Job Role
Medical, Healthcare, and Nursing
Employment Type
Full Time Employee
Monthly Salary Range
Unspecified
Number of Vacancies
1

Preferred Candidate

Years of Experience
Min: 5 Max: 9
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NERHADOU is Ranked among the top 50 leading corporates for 6 consecutive years out of 1200 Pharmaceutical Corporates in Egypt in terms of Market Share of Pharmaceutical Products’ Domestic Sales (2019).

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