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.