Senior Quality Assurance Specialist

SRG; West Yorkshire; On-site; GBP 35,000 - 55,000; Full time

Job description

Job Description

Job Title: Senior QA Officer – Quality Systems

Salary: Highly competitive basic with shift allowance, bonuses & benefits!

Location: West Yorkshire

SRG is exclusively working with a global pharmaceutical company who require a Senior QA Officer to join their well-established Quality and Operations team, responsible for managing quality systems.

This role involves ensuring all Quality Assurance activities are planned and executed in line with company SOPs and GMP Requirements and Regulations.

Responsibilities:

1. Writing and reviewing Quality documents, protocols and reports in accordance with procedural requirements and current regulatory standards.
2. Leading and authoring risk assessment, FMEA and other root cause analysis techniques to provide appropriate information on product and processes.
3. Leading the execution of Sitewide QA activities and ensuring all deliverables are met within agreed project/ procedural timescales.
4. Works in collaboration with other departments.
5. Identifying quality events and potential root cause determination and raises appropriate corrective and preventative actions.
6. Supporting and owning quality events investigations/ root cause analysis cross functionally.
7. Raising and progressing Change Controls as required.
8. Recommending, developing and implementing systems to improve QA activities.
9. Supporting with Process improvement projects and Tech Transfer of new products ensuring the process is performed in line with procedural and regulatory requirements.
10. Leading Internal Audits.
11. QMS Reviews and closures.
12. Acknowledging responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.

Requirements

1. Relevant University degree along with extensive, recent experience of working in a pharmaceutical GMP environment within quality assurance.
2. Ability to work in a team with great attention to detail to help deliver effective management of the pharmaceutical QMS.