Quality Assurance Specialist

**Quality Assurance Specialist**
**Manchester**
**Temporary ongoing 3-6 months**
**£19.20 per hour**
Kelly Life Sciences have partnered with a global biotech business based in Manchester to recruit for their growing team. We are keen to speak with experienced Quality Assurance Specialists from either the Biotech, Pharma or Med Tech industries.
You will be responsible for key interactions across multiple functions and levels of the organisation, predominantly comprising of Quality, GMP Manufacturing, MSAT and Supply Chain both at local and global levels.
Reporting in to the Quality Manager and working within a team of QA professionals supporting the development, deployment and maintenance of a complaint Quality system.
To work with the global Quality team to align / harmonise Quality systems across the organisation.
Duties & Responsibilities (KRAs) Responsibilities included below.
Provide QA oversight and support for the following key Quality systems including (but not limited to):
Document Control, Deviations, OOS & CAPA, Change Management, Internal & external auditing, Supplier Management, Quality Risk Management, Inspection Management, Material Review Board,
GMP Training & Licence oversight
- HTA oversight (assigned DI)
- Quality Management System -KPIs and reporting
- Recalls & Complaints
- Provide sufficient resource and expertise to support the following activities:

- Review and approval of new and updated documents requiring Quality review.
- Review and approval of QC data and general QA support for QC activities.
- Provide Quality representation to participate in / contribute to company projects.
- Support the batch release team in batch linked document review and approvals
- Gather (and respond to) metrics for use in tracking of performance of the health and compliance of Quality on site.
- Optimise Quality Systems and ways of working to drive a culture of continuous improvement.
- Provide site-wide quality support to all departments working within the Instil Bio GMP functions as required.
- Chair Quality meetings and represent the Quality function in company meetings and projects.
- Provide training in the respective Quality systems.
- Provide GMP guidance and support.
Skills & Abilities
- Excellent organisational and planning skills.
- Excellent written and communication skills - ability to present / communicate information succinctly across all functions / levels of the organisation.
- Good team working skills
- with ability to influence personnel throughout the site in order to promote Quality principles and improve performance.
- Personable with the ability to tactfully challenge to get the best outcome
- Good problem solver.
- Ability to communicate effectively.
- Ability to disseminate complex information and quickly act upon.
- At least four years of practical experience in pharmaceutical production or Quality Control. Among which at least one year in QA working within Quality Systems.
- Administration implementation and / or optimisation of GMP Quality Systems within a manufacturing organisation for sterile biologics medicinal products
- Experience working in a regulated environment for example: MHRA, FDA, HTA
- Experience of continuous improvement and implementation (and use) of KPIs to increase performance
Your knowledge will include a good understanding of legislation and guidance documents relating to the manufacture of Advanced Therapy Investigational & Medicinal Products as well as boasting excellent knowledge of Quality Systems and ability to provide soundQuality judgement to identify and mitigate risk and to facilitate change without compromising on Quality
You must have the ability to communicate and influence effectively at all levels and across all functions within the organisation.
Be pragmatic and intuitive in identifying solutions when dealing with quality challenges
Have a positive disposition with 'can do' attitude.
Work with a sense of urgency with sound ability to prioritise according to business needs.

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