Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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 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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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.

Audit and Supplier Qualification Specialist

Job Description