Job Information
PCI Pharma Services QA Officer in Bridgend, United Kingdom
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 the certification and release of medicinal products in accordance with regulatory, company and project requirements.
Main Responsibilities :
Support QPs 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.
Specific Qualifications :
- 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.
Previous Work Experience
Ideally, candidates will have experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
Candidate's with experience in a Quality Assurance role with a demonstrable, transferable skills may be considered.
Specific Knowledge / Skills Competence:
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.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled