Description
For one of our clients in the pharmaceutical industry, we are currentlylooking for a QA Validation Project Manager
Start: 1/7/13
Length: min 3 months
Location: South of Brussels
FUNCTION DESCRIPTION
- Provide QA support to validation activities
- Take the responsibility for QA in new projects
- Assure regulatory inspection readiness (L2 - L3/L4)
KEY RESPONSIBILITIES
- Ensure the compliance in all validation activities
- Approve change control (linked to project/validation - 1 building)
- Approve the validation documentation regarding the GMP requirementsand the vaccines procedures: URB - Basic design
- Approve the design qualification according to the GMP requirementsand the Basic design
- Owns and write the Validation master plan of projects
- Review/Approve IQ/OQ/PQ Protocols (including raw data)
- Review/Approve IQ/OQ/PQ Reports (including raw data)
- Approval of risk assessment
- Ensure timely escalation to Mgt of critical issues during validationand/or project
- Review and approve the potential CAPA plan issued from deviation orinspection
- Perform internal audit (L2) of validation activities
- Contribute to external audit (L3 corporate/L4 Belgium ): before -during - after
- Ensure implementation of validation related commitments towardsinternal/external inspections
- Review and approve the system periodic review
- Pro-actively identify potential quality and compliance risks andmanage these risks through the risk register and quality plan process
- Attend the BU Quality council and Risk register meeting
- Provide a compliance expertise in all BU projects
- Ensure QA oversight of GTS Facility project from URS up to SAT
- Ensure the compliance in the Projects & Attend all projectmeetings as QA expert
- Work in autonomy with supervision/coaching
PREREQUISITES
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy,Industrial or Civil engineering)
- Proven experience and references in a pharmaceutical, biological orbiotechnical environment.
- At least 4 to 5 years of experience in Prod., Valid. or QA in abiopharmaceutical industry
- Filling or packaging equipment validation, process Control and CSVValidation, Autoclave and Cleaning Validation knowledge would beconsidered an added value.
Knowledge
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
- Team spirit
Challenges
- Your role is to become the responsible QA involved in the validationof the Wilco (verifies the absence of cracks in the vials) leak tester, after training to the current client's procedures and thenecessary qualifications needed for the job.