Description
Are you a QA/Validation Engineer interested in working for one of Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: QA/Validation Engineer
Rate: Negotiable
Location: Cork
Positions Available: 1 Engineer
Type: Contract (3 months)
A Fantastic new role has just opened up at one of our leading Irish 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:
- Coordinate and/or perform the Design, Installation and Operational Qualification of new or changed process systems, equipments, utilities and facilities.
- To assure cGMP compliance in all activities related to validation/qualification of equipment, utilities and facilities
- To co-ordinate and coach QA, Engineering, Maintenance and Manufacturing areas, promoting a quality culture compliant with the applicable regulations and approved procedures
- To promote Quality Culture on site
- To assure cGMP compliance before, during and after validation/qualification activities by assuring that all necessary procedures are implemented and are being followed on the site;
- To assure that process systems (including automated process control systems), equipment, utilities and facilities are qualified/validated according to their intended use and product requirements in accordance with the clients Procedures and Regulatory Guidelines
- To promote the importance of high quality standards and the importance of a continuous improvement culture in core company activities;
- To participate in the alignment and harmonization of the Qualification and Validation procedures within all sites as required.
- To align Qualification and Validation methodologies in Automation, Engineering, Maintenance, and Production Areas to benefit systems compliance.
- To plan and/or establish Qualification/Validation requirements for each project;
- To establish the required qualification activities of new or changed systems and/or facilities within the change control process.
- Approve Qualification and Validation related documentation (eg: Protocols, reports, plans, change control, procedures
- Assess and approve equipment, maintenance and automation Change Control Requests
- Take decisions on qualification/validation related issues
If you are interested please do not hesitate to email or call me!
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