QA Validation Consultant
QA Validation Specialist - Global Pharmaceutical Client – 6 Month Contract in Brussels, Belgium
Our client, one of the world’s largest pharmaceutical organisations is responsible for developing and manufacturing medicines, consumer products and vaccines for a wide range of medical disciplines. They have been responsible for the development of several key and revolutionary products and have a presence in the USA, EU and Asia-Pacific.
With continued organisational growth and a considerable amount of investment across the portfolio and capital programme, they are currently seeking the expertise of QA Validation Specialist to join their team on a contract until the end of 2020.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Ensure QA oversight in validation activities (IQOQ / PQ / PV)
- Review/Approve the validation documentation regarding the GMP requirements and the internal procedures
- Ensure that production practices are aligned with validation conclusion
- Attend all project meetings as QA validation representative
- Ensure timely escalation to Management of critical issues during validation
- Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
- To define the validation strategies through the change control process
- To write and implement some validation documentation (Validation Plan, Validation
- Summary Report, Risk Assessment, Gap Analysis, Periodic review ….)
- To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
- To support the production, QA, and technical service teams in the implementation of the validation activities.
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- Good oral and written communication skills in French & English
- Former relevant industrial experience related to the requested seniority in
- Validation and QA in a biopharmaceutical industry.
- Knowledge of GMP / CFR / EudraLex
- Knowledge of different regulations and standards related to validation activities
If you are interested in this role, please apply now for more information!
The candidate must have the rights to work in the location stated in the job advert.
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