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Job Description
Job Purpose:
Manage and ensure implementation of validation work activities and relevant validation documentation including facility equipment, manufacturing process, cleaning and computer system validation as well as bulk holding time studies in Cairo site.
Key Responsibilities:
- Accountable for all validation activities in the site and responsible for implementation of validation life cycle.
- Prepare and update site validation master plan (VMP) for Cairo site, stating the scope, rationales and Schedules.
- Accountable for validation working parties for planning and coordinating the different validation activities and deliverables related to new systems, facilities, equipment, processes or products.
- Ensure conducting all validation activities as per GSK QMS requirements.
- Follow up and ensure that required validation documentation DR/IQ/OQ/PQ protocols, reports, interim reports and validation summary reports are prepared and approved for new or upgraded machines, analytical equipment and IT systems.
- Ensure effective implementation of Computer system validation (CSV) life cycle as per CSQMS, AEQMS and 1TMS.
- Ensure keeping site computerized system register updated as per 1TMS requirements.
- Ensure cleaning and process validation programs are being implemented based on scheduled plan.
- Ensure effective implementation of validation review practices for scheduled utilities, Equipment and computerized systems.
- Ensure effective implementation of validation review on products and cleaning processes as per QMS requirements.
- Endorse completion of all validation work required for change control requests up to their final closure.
- Approve training curricula for department representatives and ensure curricula is relevant to job description.
- Identify validation related risks and ensure adequate management of corresponding mitigation plans.
- Responsible for technical and personal development of direct reports by using effective appraisal, performance management and implementing training for validation organization.
- Present validation updates and KPIs for quality councils and performance management.
Job Requirements
- University Bachelors' degree of Engineering or Pharmaceutical science.
- Minimum 5 years’ experience in a similar position.
- Work experience a multinational pharmaceutical company is an advantage.
- Good background of pharmaceutical manufacturing requirements and good understanding of CSV.
- Knowledge of EHS, GLP and GMP requirements.
- Good command of English language and computer skills
