Quality Assurance Officer
Job Title: Quality Assurance Officer
Work Pattern: 40 Hours per week
Reporting to: QA Manager
Responsible for (staff): N/A
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.
Essential Duties and 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 but not limited to Internal audits, vendor management, deviations/complaints, Corrective and Preventative Action (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.
- Deliver internal QA and Good Manufacturing Practice (GMP) related training.
- 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 profile 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.
- 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.
- 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).
- Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level of self-motivation is required
- Able to rationally persuade.
- Influencing skills
- 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.