Quality Assurance Associate Manager
FUJIFILM Diosynth Biotechnologies :
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force.
Whilst working as QA Associate Manager in the Quality team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity.
About Us:
We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.
With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.
Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.
Role & Responsibilities:
- Management of the backroom support for client audits and co-ordination with hosts on expectations pre and post audit.
- Working across the business with SMEs and Quality Programme Managers to deliver client demands across the audit experience
- Management of the Inspection Readiness process, managing system leads and escalation risks associated with inspection readiness.
- Management of Internal and Supplier audits for FDBK ensuring delivery and metrics detailing delivery and outputs to steering and QMR.
Qualifications and Experience:
- A minimum of 5 years’ experience in a GMP/GLP environment
- Applied Knowledge and proficiency of QA systems: (for example, Events/Deviations, CAPA’s, change control)
- Demonstrate a sound knowledge of how the principles and practices of GMP are applied to areas of responsibility.
Why work with us?:
At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.
When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:
- Competitive salary plus company bonus scheme
- 35 days of holiday, plus bank holidays.
- Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
- Generous pension scheme
- Free parking and electric charging points
Closing date 24th January 2025
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