Audit and Supplier Qualification Specialist

## Audit and Supplier Qualification SpecialistApply: Stamullen, Co. Meath, IRL: Full time: Posted Today: JR 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.We have a maternity cover opening to join our Stamullen Team. Key Responsibilities * Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.* Ensure on-going compliance with customer, regulatory and internal requirements.* Management and co-ordinate all aspects on site Supplier Management Programme, including supplier audits, preparation of QTA’s and supplier qualification.* 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* Ensure activities observed are in compliance with the requirements of cGMP* Generation of SOP/Forms/JA's/WI's on MasterControl* Support, participate and host both Client and Regulatory audits.* 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 companyKnowledge / Skills & ExperienceEssential:* 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’ experience in supplier management and auditing experience is preferred with particular emphasis on hosting and conducting audits.* To have demonstrable experience within Quality Systems.* Lead auditor qualifications would be advantageous.* 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
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