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.
Main 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.
- 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.
Work Experience & Skills Required
Essential
- 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
- Excellent written and verbal communication.
- Ability to perform audits, internally and externally.
- Quality Officers need to be familiar with standard computer applications currently in use by the company.
- Communication skills – Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations.
- 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.
Desirable
- Attitude embracing company vision and values.
- Analytical thinking and Problem Solving.
- Willingness to travel on company business.
- Judgement and decision making.
- Self Confidence.
- Self-Motivation/ achievement drive.
Qualifications:
Essential
- 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.
Desirable
- 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).
- Experience in a Quality Assurance role within an industry with transferable skills.
- Holds a qualification in a life sciences subject (level 4 or above).
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.
