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QA Manager

£Competitive | South East, Berkshire |  Quality Assurance and Supply Chain, QA |  Permanent  | Ref:889390

The Role

QA Manager - Biotech - Berkshire - £Competitive

 

The Company

Our client is a global, market leading biotech company that manufacture and distribute treatments for oncology, neurosciences and rare diseases therapy areas.

 

The Role

Our client is looking for a QA Manager to join their External Manufacturing team in Berkshire! The ideal candidate will be highly experienced with the potential and drive to move into a Director position within the next 2 years. Responsibilities include;

  • Deploy and maintain GxP Quality Management Systems with CMOs and Testing

  • Laboratories to ensure compliance with regulations and inspection readiness at all times.

  • Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.

  • Ensure that critical quality issues are reported to company management using the Global Quality alert process.

  • Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.

  • Carry out the disposition of Finished Products, APIs, Raw Materials and Components when required.

  • Identify and implement opportunities to simplify EMO business processes including sampling, testing and data generation.

  • Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.

  • Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing

 

You

  • MSc in a Life Sciences discipline

  • 7 years hands-on experience gained in both Quality Assurance and Quality Control departments

  • At least 3 years in a Supervisory position

  • Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.

  • Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections

  • Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.

  • Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.

 

What should you do next?

This QA Manager role is one not to be missed; it encompasses the opportunity to develop a strong QA career within a global, reputable biotech company! To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Nadya Libecans

Which team and area do you work/specialise in?

I work on the Drug Development team specialising in Quality (QA) and Supply Chain roles within the pharmaceutical, medical devices and consumer healthcare markets.

What are some of the typical roles you cover?

I cover all levels from Administration to Director level within QA, QC, Supply Chain, Procurement and Logistics.

What are the hot issues in your sector currently?

For both Quality and Supply Chain, Brexit is a huge topic at the moment. Clients and candidates I work with have been working extensively to organise contingency strategies to minimise the effects to cost of manufacture and speed of product delivery.

Who is your biggest idol / inspiration and why?

I have two. Firstly, my mum who is the strongest role model I have in my life. She has taught me the importance of independence, security and resilience. Secondly, I’d have to say Catherine Ryan who has proved that you can really have it all and a sense of humour.

What is your greatest fear?

Being unsafe – the thought of not being able to get out of a situation where you feel you might die. Safe to say, I will not be climbing Snowdon again!

How would your friends describe you in three words?

Independent, nurturing and fun

You’re stranded on a desert island – what one thing could you not live without?

A Swiss army knife so I can open coconuts, hunt and make a shelter

What’s makes you #DistinctlyDifferent?

I believe knowledge is power and I strive to learn as much about people and the industry as possible to build lasting relationships and produce the best results for candidates and clients. 

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