Description
Are you a CQV Engineer interested in working for one of the Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: CQV Engineer
Rate: Negotiable (Euros)
Location: Cork, Ireland
Type: Contract (12 Months Rolling)
A Fantastic new role has just opened up at one of our leading Cork 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 ASAP- We need YOU
Responsibilities include:
- Development of C&Q strategy/plans and input to scheduling activities for busy small projects group, in line with site standards for CQV
- Preparation and review of documents associated with life cycle of C&Q activities including Validation Master Plans, RVs, IVs, FAT's, Risk Assessments, DQ, IQ, OQ, IC, OC and summary reports.
- Experience in and/or understanding of:
- Equipment validation
- Facilities validation
- HVAC system validation
- Cleaning validation
- Process Validation
- Analytical method validation
- Supporting the client in determination of URS's and FRS's and have an understanding of PQ requirements and associated review
- System/Equipment Classification Reviews
- Oversight and implementation of the CQV Program, ensuring quality delivery
- cGMP Reviews
- Active participation with Client QA group to ensure compliance with procedures and provision of support to the QA Quality team in audit preparation
- Change Management activities during project life cycle, ensuring completion and required sign-off
- Ensuring data integrity and quality culture in all aspects of project execution
- Summary report writing/metrics/schedule reviews
- Oversight and implementation of the client CQV Program, ensuring a quality delivery
- Interfacing with representatives on project team, Construction, Engineering, Automation, End Users during the different project phases and throughout all levels
- Understanding of FDA, MHRA requirements, GMP and GEP
Requirements
- A degree in science or engineering or equivalent OR A certificate/diploma in similar areas with appropriate industrial experience
- Extensive experience of CQV activities in a project environment within the pharmaceutical or biotech industries
- Ability to work on multiple small projects at different phases of execution
- Experience of variety of Biological equipment and utility systems
- Experience with Regulatory and industry standards for GMP and GEP
- Exhibit excellent quality behaviors
If you are interested please do not hesitate to email or call me!
(see below)