Description
Are you a CSV Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Equipment Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: CSV Engineer
Rate: Negotiable
Location: Dublin
Type: Contract (12 Months)
A Fantastic new role has just opened up at one of our leading Dublin based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is u - We need YOU
Responsibilities include:
- You will need to review Project Quality Plan, and ensure good communication to project team, providing training where necessary.
- You will have to provide guidance, training and updates on GAMP/GMP (current and future versions)
- You will be assessing support that they require and services that may be sold to them.
- You will have to work with customers to establish project validation strategy (VMP, VP) and ensure this is reflected in the clients testing strategy (OTP, Test specifications)
- You will need to provide compliance and risk management guidance for projects to ensure consistency with compliance standards and the adherence of deliverables.
- You will have to assist in developing project strategies to mitigate this risk.
- You will have to assist in reviewing of User Requirements to ensure they deliver the necessary information to the project team and comply with GAMP guidelines, FDA rules and other pharmaceutical regulations.
- You will have to ensure that the team is focussed on User Requirements, co-ordinate project traceability and assist in reviewing project documentation (FS, CS, DS, test specifications)
- You will help to develop configuration and change management strategy with lead engineer, and enforce its use.
- You will have to perform training at the start of test phases, to ensure testers understand their responsibilities.
- You will have to perform validation of project test records. Communicate issues, resolve them with the project team and take leadership in closing issues before solution delivery
- You will be assisting the customer in developing IQ, OQ and PQ protocols/templates and SOPs.
Requirements
- A proven experience with IT Quality Management and Computerized Systems Validation (GMP, 21CFR Part 11, GAMP) together with PCS/MES application implementation and deployment in the regulated pharmaceutical industry including awareness of customers' responsibilities
- A good knowledge of European and International major pharmaceutical regulatory requirements
(FDA, EMEA, ICH) - Trained in ISO 9001 with auditor training and relevant experience
- Ability to influence the culture of a project team or department to adopt and maintain good quality standards
- Experience in Quality Management and Quality Systems development.
- Proven experience and personal credibility in front of customers and colleagues is essential.
- Member of ISPE, with involvement in Communities of Practice to ensure current knowledge.
If you are interested please do not hesitate to email or call me!