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Senior Quality Assurance Specialist

Job Description

Senior Quality Assurance Specialist

(Limerick based)

Are you interested in joining our client in integrating new products into a regulated SDLC, driving process improvement, and developing quality management systems?

As a Senior Quality Assurance Specialist role:

Our client has a strong reputation in our approaches to clinical development and provides innovative strategies to the drug development process. The Senior Quality Assurance Specialist works closely with management teams, internal/external clients and vendors or suppliers. You will develop and manage SOP’s while also reviewing and approving Systems Development Life Cycle Role (SDLC) documentation to assure regulatory compliance.

Our client is presently in over 40 countries with over 80 offices worldwide and over 11,000 employees globally. In this role you will be working closely with Clinical Development and Software Development Teams in bringing new technology to the fore via their SDLC process.

To succeed you will need:

They are seeking a Bachelor’s degree and at least 3 years of Quality Assurance experience with a strong working knowledge of GCP, GxP and QA Principles. Successful candidate will have experience within a Pharmaceutical, Medical Device or CRO. One will need to have a working knowledge of SDLC methodology, computer system validation and 21 CFR Part 11 including auditing against these regulations.

Benefits of working here:

They provide the Senior Quality Assurance Specialist a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance. Additionally, they have cutting edge technology that will allow you to analyse study specific processes/documentation, audit reports, and governance to quality system checks and ensure compliance.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

Our client is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.