QAV Specialist
- Denmark
- Contract
- CAPEX Projects
This vacancy has now expired
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a QAV specialist 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:
- Support and manage SAT, IQ, OQ and PQ activities.
- Create, approve and maintain quality plans and procedures, risk assessments, reports and support inspection readiness
- Ensure coordination of Commissioning and Qualification activities for the defined equipment in charge with qualification matrix according to planning, cGMP conformance and internal Standards
- Review and approve SAT/IQ/OQ and PQ for major process equipment, primarily the isolator based filling line
- 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, Risk assessment, change control management, covering Process-and support equipment IT/Automation Scada, clean utilities and facility.
- Aligning with the DP PQA Team and project leads on requirements
- QA involvement in clean room area readiness and qualification
- Participate to oversight over project change management planning and execution
Requirements:
- Minimum 5 years QAV Biotech experience on Large Scale Projects
- SME on all Quality and Compliance issues - minimum 5 years
- Working knowledge of ASTM E2500 / Leveraging Verification process
- Minimum of 5 years of Biotech experience including experience with design and construction projects for manufacturing facilities.
- Experience with complex projects and working in or around operating facilities.
- Ability to keep work pace and meet deadlines. Good organising and planning skills.
- This individual must have had experience of a similar project with a multi-million capital spend.
If this role is of interest to you, please apply now!
#LI-ML1
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
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
Save as job alert
Similar Jobs
Salary
Competitive
Location
Milton Keynes
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
East Anglia
Description
QC Biologist - Pharmaceuticals - 12-Month Contract Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines,
Reference
34674
Expiry Date
01/01/0001
Author
Tom EvansAuthor
Tom EvansSalary
Competitive
Location
Berlin
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
East Germany
Description
MEP Site Manager - Berlin - 12-Month Contract We have an unmissable opportunity to work with a company that delivers technology expertise and high-end solutions to data centre construction
Reference
34660
Expiry Date
01/01/0001
Author
Charlotte ClarkeAuthor
Charlotte ClarkeSalary
Competitive
Location
Berlin
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
East Germany
Description
MEP Project Manager - Berlin - 12-Month Contract We have an unmissable opportunity to work with a company that delivers technology expertise and high-end solutions to data centre construction
Reference
34659
Expiry Date
01/01/0001
Author
Charlotte ClarkeAuthor
Charlotte ClarkeInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Megan
I manage this role.