Audit and Supplier Qualification Specialist

PCI Pharma Services; Stamullen; On-site; EUR 50,000 - 70,000; Full time

Job summary

PCI Pharma Services in Stamullen is seeking a QA professional to manage supplier audits and ensure cGMP compliant operations on site. The role requires a degree in pharmaceutical sciences and 3–5 years of supplier management experience with audits.

Responsibilities include coordinating supplier qualification, CAPAs, NCRs, and hosting client/regulatory audits, while generating SOPs and maintaining MasterControl records. Strong communication and multi-tasking are essential.

Qualifications

• Bachelor's or associate degree or Diploma / Certificate in Pharmaceutical and/or life science. May substitute experience.
• 3-5 years' supplier management and auditing experience preferred with audits hosting/conducting.
• Experience within Quality Systems and cGMP standards.
• Lead auditor qualifications advantageous.
• Experience in Quality Assurance/Quality Systems/Compliance.
• Ability to follow clear goals and communicate progress to targets.
• Ability to manage multiple tasks and priorities with good interpersonal skills.
• Strong written communication skills.

Responsibilities

• Ensure safe work practices and regulatory compliance on site.
• Manage supplier audits, qualification, and QTA preparation.
• Raise Deviations, CAPAs, and NCRs and communicate with auditing Manager.
• Ensure activities comply with cGMP and related regulations.
• Generate SOPs, Forms, JA's, and WI's in MasterControl system.
• Support and host Client and Regulatory audits.
• Interact daily with staff and support departments.
• Lead ad hoc projects to meet department needs.
• Carry out additional tasks to support company goals.

Skills

Supplier management

Auditing

Quality systems

cGMP knowledge

Lead auditor

Regulatory knowledge

Communication skills

Written communication

Project management

Education

Bachelor's degree in Pharmaceutical/Life Science

Diploma / Certificate in Pharmaceutical and/or Life Science

Associate degree in Pharmaceutical/Life Science

Job description

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 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.
• 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

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.