About this role
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Position overview ProPharma is continuing to support one of the most exciting and innovative life-sciences as they require key support for the Person-In-Plant activities across their CDMO partners in the EU. This project is to commence immediately and offer short term support for three months initially; it offers 1.0 FTE (40 hours a week) and it requires travel to sites for two/three weeks within the contract to CDMO partners across the UK/EU. Key responsibilities Lead and manage routine Quality Management Reviews (QMRs) Provide quality oversight and support during Process Performance Qualification (PPQ) activities for both clinical and commercial products, ensuring compliance with applicable quality and regulatory requirements.
Act and perform key audits related to these findings Coordinate and deliver mock inspection readiness activities, including preparation, coaching, documentation review, and support for inspection simulations. Perform a variety of QMS tasks which includes CAPAs, deviations etc. Support inspection and audit readiness initiatives across clinical and commercial manufacturing operations.
Collaborate with cross-functional stakeholders to ensure quality risks are addressed and resolved Review and evaluate quality systems, documentation, and manufacturing activities to ensure alignment with GMP requirements and company quality standards. Act as a quality subject matter expert for assigned projects and quality-related initiatives, providing guidance on compliance expectations and quality system requirements. Overall key support to all Person-In-Plant activities from a QA Lead perspective Skills required Must be educated to a BSc or higher within a life-sciences discipline Thorough experience working in Quality Assurance within the Life-sciences industry Previous experience either working as a Person-in-Plant or supporting them is key for success Previous experience managing CDMO partners would be highly preferred Fluent in English Currently based within the UK or EU Can perform the project as designated within the job description We celebrate our differences and strive to create a workplace where each person can be their authentic self.
We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.
Please, no phone calls or emails to anyone regarding this posting.***