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.
General Purpose of Role:
To perform a Quality Assurance role which supports:
Certification and release of medicinal products in accordance with regulatory, company and project requirements.
Maintain, support and improve the Pharmaceutical Quality System employed within PCI.
Main Responsibilities:
Support the QP in execution of their legal and operational duties.
Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
Reporting of 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 offsite shelf life extension labelling activities.
Pre-approval assessment of change controls and deviations.
Co-ordinate and perform investigations into internal and external quality issues.
Assess temperature excursions during shipment in line with the stability priofile of the product(s).
Approval of 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.
Previous Work Experience:
Minimum two years experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
Experience within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
Holds a qualification in a life sciences subject (HNC, HND or degree or equivalent) in a life sciences subject 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 other regulatory guidelines preferable.
Strong communication skills.
The ability to introduce, co-ordinate, complete and report on projects.
A high level of self-motivation is required.
Able to rationally persuade.
Quality Officers need to be familiar with standard computer applications currently in use by the company.
Interpersonal skills: able to form and maintain relationships at all levels is essential. A Quality Officer must be able to effectively convey potential quality issues and offer constructive advice when required.
Thinking and decision making: a Quality Officer will often need to make decisions and advise on appropriate courses of action in the event of a Quality incident or to agree appropriate Corrective and Preventative actions. A Quality Officer should be able to consider all relevant aspects and possible repercussions are considered regarding these quality issues.
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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.
Skills Required
- Minimum two years experience in a Quality role within a regulated industry
- Qualification in a life sciences subject or equivalent experience in a Quality Assurance or technical role
- Good GMP knowledge and experience of EU legislation and guidelines
- Strong communication skills
- Familiarity with standard computer applications currently in use
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
