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- Tasks: Lead quality assurance efforts, ensuring compliance with GMP and GDP in a dynamic pharmaceutical environment.
- Company: Join a growing generics pharmaceutical business with a strong reputation and experienced leadership in London/Hertfordshire.
- Benefits: Enjoy a hybrid work model, corporate perks, and a collaborative culture that values your contributions.
- Why this job: Be part of a fast-paced team focused on quality and continuous improvement in the healthcare sector.
- Qualifications: Degree-level qualification and 5+ years of QA experience in pharmaceuticals required; MHRA RP status preferred.
- Other info: Opportunity to lead a small QA team and drive impactful quality initiatives.
The predicted salary is between 48000 - 72000 £ per year.
We are currently recruiting for a Quality Assurance Manager to join a Generics Pharmaceutical business in the London / Hertfordshire area. This is a hybrid role, working a minimum of 3 days per week in the office.
About the business you are joining: Our client is a growing Pharmaceutical business who provide generics into the primary and secondary care sectors in the UK. Benefitting from a highly experienced leadership team, the business has really good partnerships and has established a very strong and reputable brand within the industry. At the same time, the business is constantly looking at growth opportunities, so you must be prepared to roll your sleeves up and play an active role in contributing to the future success. The culture within this business is great too - it is dynamic, fast-paced and very collaborative, so we are looking for individuals who thrive in such environments.
About the Quality Assurance Manager role: The Quality Assurance Manager role is responsible for supplier qualification, oversight and assessment of GMP activities performed at suppliers' manufacturing sites, confirming that the storage and transport of products is compliant with GDP, and that all customers are vetted. In addition, the Quality Assurance Manager role involves QA review of batch records and transportation documents and coordinates/reviews QC testing to ensure all finished products meet applicable GxP and associated requirements and regulations. It will be essential for the Quality Manager to work as a key point of contact for Quality, coordinating correspondence with suppliers and customers to ensure timely provision of information needed for batch release and to demonstrate continued compliance.
The key responsibilities for the Quality Assurance Manager role will involve the following:
- Maintenance of the registers and folders of supporting documentation
- Investigation of Deviations and Complaints, raising and management of CAPA
- Initiation and management to closure of Change Controls, CAPA, Supplier Complaints
- Onboarding of suppliers and customers, Bonafide’s and annual requalification
- Oversee third-party logistics providers (3PLs), ensuring distribution practices align with GDP requirements
- Maintenance of Supplier Risk Matrix and Training Matrix
- Management and completion of supplier and customer queries
- Management of QA inputs to QTAs, TAs and SLAs
- Assessment of Route Risk Assessments and creation of Supply Chain maps
- Management of returns and stock destruction
- Updating procedures by due date or before as improvements identified
- Trending of QMS metrics, creation of reports and hosting Quality Review Meetings
- Management of QMS to maintain an ‘audit-ready’ status
- Management of any recall activities including mock recall
- Lead Self-Inspections, and adhere to self-inspection schedule at all times
- Conduct external audits as required
- Communication with UK testing labs and warehouse/distribution sites to ensure readiness for receipt of product/samples for testing
- Authoring of PQRs and other annual reviews
- Initiation and driving to completion Continuous Improvement initiatives
- Support timely QP and RP/RPi release by collating, reviewing, completing, and filing required documents
- Ensure that the artwork of the QC samples aligns with the artwork parameters mentioned in the Product Compliance Summary (PCS)
- Review all transportation documents including journey details and temperature logger data to ensure compliance with storage conditions, route risk assessments, Supply Chain Map, etc.
- Retain all electronic and hard copy documentation in compliance with procedure
- Accurate and full completion of all forms in line with the above reviews
The ideal candidate for the Quality Assurance Manager role will have the following:
- A degree-level qualification in a relevant discipline and 5+ years’ QA experience in a Generics Pharmaceutical environment
- A proactive approach to Quality Assurance, and enjoys working in a collaborative environment
- You will ideally be an MHRA approved Responsible Person (RP)
- Demonstrable knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Comfortable leading a small, but growing QA team
Quality Assurance Manager - Generics, Pharmaceutical employer: Radar Recruitment
Contact Detail:
Radar Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager - Generics, Pharmaceutical
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines related to GMP and GDP. Understanding these will not only help you in interviews but also demonstrate your commitment to quality assurance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical sector, especially those who work in quality assurance. Attend industry events or join relevant online forums to connect with potential colleagues and learn more about the company culture at StudySmarter.
✨Tip Number 3
Prepare to discuss your experience with CAPA, change controls, and supplier management during the interview. Be ready to provide examples of how you've successfully handled these processes in your previous roles.
✨Tip Number 4
Showcase your leadership skills by discussing any experience you have in managing teams or projects. The role requires someone who can lead a small QA team, so highlighting your ability to motivate and guide others will be beneficial.
We think you need these skills to ace Quality Assurance Manager - Generics, Pharmaceutical
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance within the pharmaceutical sector. Emphasise your knowledge of GMP and GDP, as well as any leadership roles you've held.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that demonstrate your proactive approach to Quality Assurance and your ability to thrive in a dynamic environment.
Highlight Relevant Skills: Clearly outline your skills related to supplier qualification, CAPA management, and QMS maintenance. Use examples from your past work to illustrate how you have successfully managed these responsibilities.
Showcase Continuous Improvement Initiatives: Discuss any continuous improvement initiatives you have led or contributed to in previous roles. This will show your commitment to enhancing quality processes and your ability to drive change.
How to prepare for a job interview at Radar Recruitment
✨Showcase Your QA Expertise
Make sure to highlight your experience in Quality Assurance, especially within the generics pharmaceutical sector. Be prepared to discuss specific examples of how you've ensured compliance with GMP and GDP regulations in your previous roles.
✨Demonstrate Collaborative Skills
Since the company values a dynamic and collaborative culture, share instances where you've successfully worked with cross-functional teams. Emphasise your ability to communicate effectively with suppliers and customers to ensure quality standards are met.
✨Prepare for Technical Questions
Expect technical questions related to supplier qualification, CAPA management, and QMS metrics. Brush up on your knowledge of these areas and be ready to explain your approach to maintaining an 'audit-ready' status.
✨Express Your Proactive Attitude
The role requires a proactive approach to quality assurance. Be ready to discuss how you've initiated continuous improvement initiatives in the past and how you plan to contribute to the company's growth and success.
