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Process/Analytical Lab Validation Coordinator

GSK
Cairo, Egypt
Posted 4 years ago
258People have clicked1 open position
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Job Details

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Job Description

Job Purpose

Represent validation activities with validation working parties and generate required validation documentation as well as executing/ witnessing validation activities.

Key Responsibilities:

  • Lead validation working parties for organizing validation activities for new systems, IPC, analytical equipment, spread sheets, process or cleaning validation studies.
  • Ensure validation activities and documentation are complying with mandated QMS requirements under supervision of validation section head/ validation lead.
  • Preparation of manufacturing process/packaging qualification protocols and reports with defining the appropriate control strategy, sampling plan and reflection of the outcome in respective manufacturing records.
  • Update the SOPs and ensure that the MBRs are updated to reflect the recommendation outcomes of the validation and holding activities.
  • Prepare DR, IQ/OQ, PQ protocols and reports for new systems, IPC, and analytical equipment.
  • Support the implementation of company EHS rules.
  • Prepare decommissioning protocols and conduct related activities to ensure proper spreadsheet, IPC, or Analytical lab equipment decommissioning and summarize the activity in a report.
  • Conduct bulk hold time studies and ensure batch manufacturing and packaging records are updated accordingly.
  • Support GPS implementation for managing validation different activities.

Job Requirements

Knowledge/ Education / Previous Experience Required:

  • University Bachelor's Pharmacy degree
  • 0 to 3 years of working experience
  • Previous working experience in Pharma industry is an advantage
  • Good command of the English language
  • Good Computer Skills
  • Excellent communication and interpersonal skills
  • Actively seek to improve processes, controls and expand effectiveness and efficiency.
  • Self-motivated planner with good stakeholder and people management.
  • Ability to work independently and as part of a team.

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