Project QAV Lead
- Denmark
- Contract
- CAPEX Projects
This vacancy has now expired
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Project QAV Lead to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.
Responsibilities:
- Lead up the Drug Product Project QA (PQA) through SAT, IQ, OQ and PQ activities
- Be very visible in the project and Drug Product organisation and therefore have strong stakeholder management skills
- Create, approve and maintain quality plans and procedures
- Review and approve SAT/IQ/OQ and PQ for major process equipment e.g. filling line (preferable) or automatic inspection machine
- Continuous align with CQV Project Lead on CQV process to be utilised on the project with consideration given to ASTM E2500 and leveraging from FAT into IOQ
- Review and approve updates to Validation Project Plans covering Process-and support equipment IT/Automation, clean utilities and facility
- Aligning with the DP Project Manager and project leads on requirements, maintain and manage PQA team for the duration of the project, both planning and forecast costing for the team
- QA involvement in clean room area readiness and qualification
- Oversight over project change management planning and execution
Requirements:
- You have +10 years of QA for engineering/validation experience including experience with design and construction projects, preferable with fill-finish equipment and facility
- Strong leadership skills with knowledge on how to set the direction for the project regarding quality
- Working knowledge of principles, concepts, and practices of ASTM E2500 / Leveraging Verification process
- Experience with qualification formulation, filling and/or automatic visual inspection equipment
- Deep cGMP knowledge.
- Fluent in English both verbally and in writing
- Master of Science within Pharmacy, Biotechnology, Biology, Technical Engineering or similar
If this role is of interest to you, please apply now!
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
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
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
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