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Validation Specialist
1 month ago
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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of job:
The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites. Areas of validation included are:
Process Validation (PV)
Cleaning Validation (CV)
Computer Systems Validation (CSV)
Main responsibilities:
- Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
- Comply with Site Validation Master Plan.
- Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
- Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
- Perform sampling in support of validation studies, including AQL, and cleaning validation.
- Manage tooling validations and associated documentation.
- Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
- Support complaint investigations, deviation investigations and change controls as required.
- To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder's capabilities.
- Identify and support opportunities for improving processes and or procedures.
- Perform Periodic reviews and revalidations on a scheduled basis.
- Work with Validation team to ensure a robust and compliant validation system is in place.
Join us and be part of building the bridge between life changing therapies and patients.
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