Fill Finish SME
- Brussels
- Contract
- CAPEX Projects
We are looking for an experienced Fill Finish SME for a fantastic 12-month contract based in Belgium.
Working with our client, 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.
- 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.
- 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.
- 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
- Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
Experience Required
- 5+ years of hands-on, end to end experience with this equipment in International CAPEX C&Q.
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
- Experience with Post OQ activities is preferred. (Sterilisation validation)
- Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
- ENGLISH IS A MUST (French speaking not a requirement, if candidatrs4 do then it’s a bonus)
If this role is of interest to you, please apply now!
#LI-CB1
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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