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- Tasks: Lead quality assurance efforts, ensuring compliance and overseeing supplier activities 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 making a real impact in healthcare while developing your career in quality assurance.
- Qualifications: Degree in a relevant field and 5+ years of QA experience in pharmaceuticals required; MHRA approval is a plus.
- Other info: Opportunity to lead a small QA team and drive continuous improvement initiatives.
The predicted salary is between 48000 - 84000 £ 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 latest regulations and guidelines related to GMP and GDP. Being well-versed in these areas will not only boost your confidence during 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 involved in quality assurance. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at companies like ours.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to handle supplier qualifications and manage CAPA processes. Real-life scenarios will help illustrate your problem-solving skills and proactive approach to quality assurance.
✨Tip Number 4
Research our company culture and values thoroughly. Understanding what makes us unique will allow you to tailor your responses during interviews, showing that you are not just a fit for the role but also for our dynamic and collaborative environment.
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 Key Achievements: When detailing your work history, focus on key achievements related to quality management, such as successful audits, CAPA management, or improvements in QA processes. Use metrics where possible to quantify your impact.
Showcase Team Collaboration: Since the role requires working collaboratively, include examples of how you've successfully worked with cross-functional teams. Highlight any experience leading a QA team or coordinating with suppliers and customers.
How to prepare for a job interview at Radar Recruitment
✨Know Your GMP and GDP
Make sure you have a solid understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Be prepared to discuss how these regulations apply to the role and provide examples from your past experience.
✨Show Your Collaborative Spirit
Since the company values a dynamic and collaborative culture, be ready to share examples of how you've successfully worked in teams. Highlight any experiences where you contributed to a project or initiative that required teamwork.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding deviations, complaints, and CAPA management. Think of specific situations where you had to investigate issues and implement solutions.
✨Demonstrate Your Proactive Approach
The ideal candidate is proactive in quality assurance. Prepare to discuss how you've taken initiative in previous roles, whether it was leading improvements, managing audits, or ensuring compliance with regulations.
