General Purpose of Role: To perform a Quality Assurance role which supports the certification and release of medicinal products in accordance with regulatory, company and project requirements, while maintaining, supporting and improving the Pharmaceutical Quality System employed within PCI.
Responsibilities
* Support the QP in execution of their legal and operational duties.
* Administer, control and support core systems within the Pharmaceutical Quality system as allocated by line manager, including internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
* Report metrics for systems within scope of responsibility.
* Support and host client audits of the PCI Bridgend facility.
* Support delivery of site/departmental projects and objectives.
* Support continuous improvement, validation and technical services activities.
* Author standard operating procedures.
* Provide QA and GMP related training.
Outcomes of Role
* Schedule, host and close out client audits.
* Pre‑certification assessment of batch records and generation of draft QP certificates.
* Post QP certification batch release via the inventory system.
* Review and approval of off‑site shelf life extension labelling activities.
* Pre‑approval assessment of change controls and deviations.
* Coordinate and perform investigations into internal and external quality issues.
* Assess temperature excursions during shipment in line with the stability profile of the product(s).
* Approve completed investigations, CAPA’s and change controls.
* Schedule, perform and close out internal and external audits within established timelines.
* Pre‑review of validation/qualification protocols.
Qualifications
* Minimum two years experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
* Holder of a qualification in a life sciences subject (HNC, HND or degree or equivalent) or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry.
* Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 and other regulatory guidelines preferable.
* Strong communication skills and ability to introduce, coordinate, complete and report on projects.
* High level of self‑motivation and ability to rationally persuade.
* Familiarity with standard computer applications currently in use by the company.
* Interpersonal skills: ability to form and maintain relationships at all levels.
* Ability to convey potential quality issues effectively and offer constructive advice.
* Strong thinking and decision‑making skills, able to advise on appropriate courses of action in the event of a quality incident or to agree on appropriate corrective and preventative actions, considering all relevant aspects and possible repercussions.
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.
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