Audit and Supplier Qualification Specialist Job at PCI Pharma Services (Stamullen, Co. Meath)

Job Description

The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland.

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

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
3-5 years previous supplier management and auditing experience is preferred with particular emphasis on hosting and conducting audits
Good working knowledge of cGMP and associated regulations (Eudralex Volume 4
ISO 13485)
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

Lead auditor qualifications would be advantageous