Senior Quality Specialist - Swindon, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Swindon, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Job Title:
Senior Quality Specialist

Location:
Swindon

When you're part of Thermo Fisher Scientific, you'll do exciting work, and be part of a team that values performance, quality and innovation.

As a successful, growing global organization you will be encouraged to perform at your best.

With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and chance to make significant contributions to the world.

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 4 days on/4 days off with 12 hour shifts.

Responsibilities:

Provide QA oversight 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; comportment & 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 & systembased audits.
Training/mentoring of Operations staff & QA peers.
Facilitate and attend daily operational meetings, planning and problemsolving activities.

Eh&s:

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.

Minimum Requirements/Qualifications:

Relevant sciencebased 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.

Benefits we offer.
In addition to your annual salary, based on experience, you will be eligible for annual bonus, contributory pension, private healthcare, life assurance, 25 days holiday as well as other optional benefits that can be tailored to suit you

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer