Address For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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.
ProPharma has established a new partnership with a key Life-sciences brand who are in the process of creating a new GMP facility for distribution purposes in the UK. At present, we are currently seeking the support of an experienced expert in GMP facilities review/validation who ideally has a broader skill set in a QA within the Pharmaceutical/Consumer product (healthcare) industry. This project is to commences in January and it requires 60 hours support validating the current GMP plans. This in turn will lead to further chances to collaborate and the project can be performed over the course of 1 month on a fully remote basis (15 hours per week).
Responsibilities included:
- Review the current GMP design based on our clients current URS plans and ensure the project meets the required specification for GMP Compliance
- Reviewing design diagram for cleanrooms and advise on key aspects where identified
- Support and conduct gap assessments where needed
- Offer creative solutions to areas which need improvement
- Overall act as the expert to GMP Facility review plans and offer concise advise within the field as and when required
Skills required
- Must be ideally educated in an Engineering discipline or can demonstrate key experience gained in the industry
- Validation experience is essential within the life-sciences/Consumer Healthcare setting
- Must be able to offer key expertise in GMP Facility building review
- Fluent in English
- Can perform the initial 60 hours required across January/February
- Ideally open to supporting other key milestones within the project moving forward
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***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
