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.
Summary of Role The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland.
Key Responsibilities Support, participate and host both Client and Regulatory audits.
Management of audit responses and ensure closure of actions within agreed timeframes.
On-going interaction with clients in relation to audits to ensure expectations and timelines are communicated in a proactive and timely manner Management and co-ordinate all aspects on site Supplier Management Programme, including supplier audits, preparation of QTA's and supplier qualification.
Ensure on-going compliance with customer, regulatory and internal requirements.
Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to the auditing Manager/designee Generation of SOP/Forms/JA's/WI's on MasterControl Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health ISO *****).
Experience in a similar role / working in Quality Assurance, Quality Systems, Compliance To have demonstrable experience within Quality Systems.
Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets Ability to manage multiple tasks and set priorities.
Good interpersonal skills.
Good Written communication skills #LI-JP1 Join us and be part of building the bridge between life changing therapies and patients.