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:
Key Responsibilities:
* Ensure all validation activities on site relating to facility, equipment, and processes meet client expectations 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 generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
* Manage tooling validations and associated documentation.
* E_Sure 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.
* Undertake tasks and 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 the validation team to ensure a robust and compliant validation system is in place.