QA/RA Manager - Responsible Person (RP)
Our client is a well-established, leading manufacturer working in the Medical Devices and Pharmaceutical sector and is currently launching multiple new products year on year.
This QA/RA Manager is a critical hire for the business as they are looking for an individual to take on the immediate mantle of Responsible Person (RP). With an even mixture between both quality and regulatory duties, this position will be a hands on role that requires someone to have broad pharmaceutical experience in both functions. With a competitive basic salary, bonus and benefits package, alongside the ability for some remote working, this opportunity is an excellent chance to become an instrumental part of an already successful and growing business.
• Maintenance and support of company systems to maintain compliance with GDP
• Falsified Medicines Directive project lead
• Ensure FDA, EU and National Quality regulations
• To lead new product development activities
• Ensure that timescales are met for submissions
• Some work-related travelling UK and abroad
Skills and experience:
• Responsible Person registration with the MHRA is essential
• Life science degree or equivalent professional qualification
• Direct QA and RA pharmaceutical experience
• Very good understanding of sterile pharmaceutical product manufacturing
• Excellent communication skills (verbal, written and listening)
• Integrity and openness
• Personal drive and confidence
• Adaptability and team work
Keywords: Regulatory, Regulatory Affairs, Reg affairs, ECGMP, EEC-GMP, ICH, RP, Responsible Person, standards, compliance, FDA, Notified Bodies, GDP, FMD, Falsified Medicine Directive, QA, Quality Assurance
- Quality Assurance
- Regulatory Affairs
- Responsible Person
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