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.
Primary Responsibilities
This role is aimed at individuals close to completing their QP training and offers a rare opportunity to complete that training within PCI to become a certifying QP once the educational, experience and MHRA viva requirements are fulfilled.
Within this role the Trainee with be mentored by our Certifying QP team on the active day to day responsibilities of a QP. Under supervision, the Trainee QP will complete all aspects of QP review, input into QP requirements, QP Declaration creation but will not be authorised to sign as a QP until listed on the relevant site Manufacturers Import Authorisation (MIA). The certifying QP will take full responsibility for final QP signature.
The Trainee QP will be expected to complete all training to achieve certified QP status.
Quality Operations
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Review batch documentation from Production (internal and external sources) to ensure that the entire process has been performed according to PCI QMS, customer requirements and registered critical CMC documentation (e.g. IMPD) as required, cGMP principles, and that it meets customer and agency audit documented requirements.
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Prepare for Disposition (back to PCIs QP or customer QPs) or to certify completed batches effectively, investigating deviations and establishing corrective and preventive actions, for all stages of the manufacturing processes where trained.
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Realise “right first time” objectives, tracking quality and efficiency standards.
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By direct observation and intervention, monitor the application of quality standards to enable quality processes, compliant documentation, timely corrective action and continuous improvement.
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Liaise with customer as required.
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Responsible for quality projects to improve quality and departmental effectiveness, such as, cold chain storage, temperature mapping, environmental monitoring, benchmarking, KPI management, performance management and problem solving.
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Through direct involvement in the existing PCI quality systems, provide guidance and support for the various elements, such as audits, training, SOPS, documentation, change control, complaints, investigations and CAPAs, to ensure on-going compliance with customer, regulatory and internal requirements.
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Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean six-sigma methodologies.
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Actively promote best practice in quality methods and drive continuous improvement initiatives to improve quality, cost and cycle times.
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Support the Quality team in implementation of new product introductions.
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Any other duties required by the QPs
Essential Requirements
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Bachelor’s degree in a Healthcare Science (or a related discipline permitted by the professional bodies in the UK overseeing QP accreditation).
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At least 5 years’ experience in a quality management role in the Pharma industry.
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Sound industry knowledge of the requirements of EU GMP and the MHRA.
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Extensive quality systems and quality operations experience.
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Strong organisational / time management skills.
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Effective interpersonal communications, leadership and man-management skills.
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Experience of working at management level within a similar environment.
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High motivation, flexibility and the ability to work under pressure and on own initiative.
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, Diversity, Equity, and Inclusion (DEI) 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.
