CSV Engineer
- Dublin
- Contract
- CAPEX Projects
This vacancy has now expired
This role is ideal for someone who likes a challenge and enjoys having a wide scope of responsibilities!
Responsibilities include but are not limited to:
- Generating, co-ordinating and executing Commissioning and Qualification CSV protocols for configurable (GAMP Category 4) applications to category 5 PLC controlled equipment in an FDA regulated environment (compliant 21 CFR Parts 11, 210,/211, EU Annex 11 and GAMP 5)
- Performing gap analysis, determining 21 Part 11 / Annex 11 compliance and carrying out Vendor Evaluations, GXP Assessments and 21 CFR Part 11 Assessments on GxP systems
- Responsible for generating and maintaining the Computer System Validation Master Plan and all associated systems life-cycle documentation in accordance with Mallinckrodt Pharmaceuticals site procedures and templates.
- Witnessing of Control System (BMS/PCS) Software FAT and coordination of FAT report review and approval.
- Responsible for reviewing and approving software Change Management activities during the project lifecycle while considering impact of changes to Manufacturing and Facilities equipment.
If you think you have the right experience for this job please apply now!
The candidate must have the rights to work in the location stated in the job advert.
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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
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
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