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 & Safety meetings.
* Interact and communicate daily with staff and support departments.
* To undertake such tasks and to manage specific and/or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
* Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company
Knowledge / Skills & Experience
Essential:
* Bachelor's or associate degree or Diploma / Certificate in Pharmaceutical and/or life science. (e.g. quality assurance,, or similar). May substitute experience in lieu of educational requirements.
* Previous supplier management and auditing experience is preferred with particular emphasis on hosting and conducting audits.
* Lead auditor qualifications would be advantageous.
* Good working knowledge of cGMP and associated regulations (Eudralex Volume 4; 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