Location
Swindon | United Kingdom
Job description
Quality Specialist
Currently recruiting a Quality Specialist on behalf of one our main clients.
This opportunity is initially for a 12 month contract.
Job overview:
The QA Specialist provides end-to-end QA oversight of the 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.
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 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.
- Participate in local area & system-based audits.
- 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.
Minimum Requirements/Qualifications:
- 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 organisation.
- Good organizational and time management skills.
- Proactive approach to continuous improvement and project work.
- Problem solving skills with validated ability to anticipate problems, prioritise, analyse relevant factors and develop action plans.
- Ability to search for improvement opportunities and apply new and creative solutions.
- Proven track record in making risk-based decisions, apply Quality Risk Management principles and raise at the appropriate level.
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.
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Job tags
Salary
