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 are looking for a QA Regulatory Compliance Specialist (Permanent role) to join our team in Stamullen, County Meath. This is a hybrid role (2 days a week on-site).
Summary of Role:
The role is to implement and execute tasks relating to the introduction and maintenance of third party/commercial products within the third-party Quality Assurance department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
Main Responsibilities:
- Creation and maintenance of Drug Product File (DPF) for commercial supply chain where QP certification is performed.
- Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
- Maintenance of Approved CMO list for Commercial Supply Chain.
- Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
- Ensure on-going compliance with customer, regulatory and internal requirements.
- Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
- Preparation and maintenance of the third party/clinical approved products and supplier lists.
- Preparation of QP declarations for review and approval by third party QP at PCI.
- Preparation and review of product quality reviews for third party QP release.
- Review and track third party change controls which have a product quality or regulatory impact.
- Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
- Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
- Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system.
- Identify and support opportunities for improving processes and or procedures.
- To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the jobholder’s capabilities.
Knowledge / Skills & Experience
Essential:
- Bachelor’s degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
- 3-5 years’ experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Desirable:
- Experience in auditing of external suppliers, contractors and vendors.
- Experience with regulatory filings.
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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, Diversity, Equity, and Inclusion (DEI) 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.