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C&Q Process Lead

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Life Sciences
37863
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C&Q Process Lead - Belgium, Brussels - 8 Months Contract

We are looking for an experienced C&Q Process Lead for a fantastic 8 month contract based in Belgium.
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Accountable for the team drafting or support the document drafting by a partner or supplier, coordinate review and approval of applicable C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
  • Drive verification testing, protocol execution, walk-downs, verification of system drawings, design and operational testing and troubleshoot as required.
  • Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
  • Act as C&Q Subject Matter Expert and Compliance. Ability to provide guidance/ manage supplier and all C&Q activities for the system(s), from design to field execution and to summary report approval.
  • Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
  • Accountable for the Review and acceptance by the team of turnover of equipment / system from construction group. Ensures Start-up of equipment/ system is completed in a safe and coordinated manner.
  • Generate and or review change controls related to C&Q and drive their closure in a timely manner
  • Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
  • Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
Requirements:
  • Requires extensive, hands-on, end to end experience with this equipment in International CAPEX C&Q.
  • Technical qualification at third level or equivalent in Engineering. English is must.
  • Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
  • Experience with Post OQ activities is preferred.
  • Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
  • Knowledge of safety, GMP and environmental regulatory requirements. Ability to make decision under pressure and demonstrated strong Analytical/ Communication/ Leadership skills.
  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
If this role is of interest to you, please apply now!
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