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.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Deviation Quality Specialist | 11 month initial contract | Dublin, Ireland | Global Pharmaceutical Client. Do you want to be part of one of the top 10 best companies to work for in
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