Quality Assurance Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

Position Summary:
The QA Specialist delivers the Quality on The Floor program, providing end-to-end QA oversight of the Swindon site manufacturing facilities and support functions. The role is hands on, you will assist in the early identification and resolution of issues, the timely and accurate review of GMP records and training others on quality assurance concepts and tools. Assisting with internal, client and regulatory audits will be encouraged to ensure compliance with cGMP requirements. The role will require shift work to support continuous operations.
Please note, this role will involve working shifts at our 24/7 site operation in Swindon. You’ll need to be comfortable working days and night with this role and will be compensated for this as part of the overall package.

WHAT EXPERIENCE / QUALIFICATIONS ARE WE LOOKING FOR?

• Relevant science-based degree, e.g. Chemistry, Biology, Pharmacy preferred.
• Experience working within the pharmaceutical industry, preferably in the manufacture of sterile products.
• Knowledge & understanding of cGMP & other regulatory guidelines for the pharmaceutical manufacturing industry.
• Excellent interpersonal skills with the ability to appropriately challenge behaviours at all levels of the organization.
• Good organizational and time management skills.
• Proactive approach to continuous improvement and project work.
• Problem solving skills with validated ability to anticipate problems, prioritize, analyse relevant factors and develop action plans.
• Ability to search for improvement opportunities and apply new and creative solutions.
• Consistent track record in making risk-based decisions, apply Quality Risk Management principles and raise at the appropriate level.

• Provide QA guidance to operational activities across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing, and operations support.
• Supervision of clean rooms and support areas; compliance to SOPs – including actual entry into the clean rooms and maintenance of a minimum of a L1 license.
• Review and approval of a wide range of GMP records, supporting the manufacture and release of sterile products to the marketplace.
• Generate and review quality records e.g., Deviations, Investigations, CAPA and Change Controls.
• Lead and participate in local area & system-based audits.
• Training/mentoring of Operations staff & QA peers.
• Facilitate and attend daily operational meetings, planning and problem-solving activities.
• Understand emergency procedures and follow safe systems of work.
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times.
• Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.