Audit and Supplier Qualification Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Stamullen; À distance; EUR 65 000 - 90 000; Plein temps

Résumé du poste

PCI TRGR Penn Pharmaceutical Services Ltd in Stamullen, Co. Meath, Ireland, is seeking an Audit and Supplier Qualification Specialist. The role focuses on managing the supplier qualification program, conducting supplier audits, and preparing QTA’s and qualification records.

It requires direct experience in quality systems and cGMP, with exposure to audits for clients and regulators. You will generate SOPs and forms in MasterControl, raise deviations and NCRs, and coordinate multiple tasks while

Qualifications

• Bachelor’s/associate Diploma in Pharmaceutical or life sciences or equivalent.
• 3–5 years’ supplier management and auditing experience preferred.
• Experience with Quality Systems and cGMP regulations is essential.

Responsabilités

• Coordinate on-site Supplier Management Programme, including audits and supplier qualification.
• Raise Deviations, CAPAs, and NCRs and ensure timely communication to QA leadership.
• Ensure activities comply with cGMP and related regulations (ISO 13485 is a plus).
• Generate SOPs, forms, JAs and WI on MasterControl and support audits.
• Host and participate in client and regulatory audits and liaise with staff daily.
• Carry out ad hoc projects to meet department needs and business goals.

Connaissances

Supplier management

Auditing

Quality systems

Lead auditor

cGMP knowledge

Formation

Bachelor/Associate/Diploma in Pharma/Life Sciences

Outils

MasterControl

Description du poste

## Audit and Supplier Qualification SpecialistApply: Stamullen, Co. Meath, IRL: Full time: Posted Today: JR119903Life 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