CSV Engineer
- France
- Contract
- CAPEX Projects
Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CSV Engineer to join them on their new expansion project. Based in a charming french location, this is on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.
Responsibilities and Requirements:
- Site Subject Matter Expert for Computerised Systems Validation.
- Responsible for developing and managing the site strategy towards CSV.
- Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
- Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
- Support vendors to ensure adherence to, and application of GAMP
- Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
- Work cross-functionally to ensure site alignment with lifecycle requirements.
- Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
- Support development of CSV competencies within both Validation and across the business.
- Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
- Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment always meets regulatory requirements with a target of zero impact to routine operations.
- Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
- Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
- Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
- Application of risk and science-based tools to drive execution strategies and support issue resolution.
If this role is of interest to you, please apply now!
#LI-IB1
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.
Iain
I manage this role.