Job descriptionLife 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: Co-ordinate and manage the Bridgend client and regulatory audit schedule. Support Bridgend supplier and depot audit schedule. Ensure all audit actions are closed in a timely manner. Support and improve the Pharmaceutical Quality System employed within PCI. Main Responsibilities: Co-ordinate and manage the Bridgend client and regulatory audit schedule. Manage the supplier, audit, and risk module within Master Control (PQS) for the ongoing audit system at Bridgend. Supporting Bridgend regulatory site licences. Support continuous improvement projects and opportunities. Outcomes of Role: Schedule, host and close out client and regulatory audits. Support with any quality related questionnaires for customer vendor approval of Bridgend Support audit events, actions, and any audit change controls activities. Support, perform and close out internal and external audits within established timelines. 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: Meets one of the following requirements: Experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device). Experience in performing audits, internally and externally. Experience generating reports or technical documentation within a regulated industry. Experience in a Quality Assurance role within an industry with transferable skills. 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 close audit reports. A high level of self-motivation is required. Able to rationally persuade. Influencing skills Need to be familiar with standard computer applications currently in use by the company. Behavioural Competencies: 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. Must be able to effectively convey potential quality issues and offer constructive advice when required. Thinking and decision making – will often need to make decisions and advise on appropriate courses of action in the event of an audit observation 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. 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.
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