Q&RA Engineer Job at Brook-St Hiredonline (Basingstoke)

Job Description

We are currently recruiting for a Q&RA Engineer to join a fast-paced and highly regulated manufacturing environment. This role will focus on providing quality oversight through documentation review, process monitoring, investigation support, and collaboration with cross-functional teams to ensure compliance and continuous improvement across quality systems. This is a 9-Month contract with the possibility of an extension.

Job Responsibility

Provide support and maintain compliance with GMP/GxP, ISO, and regulatory requirements
Investigate quality issues and support root cause analysis activities
Manage and support change control processes
Conduct and support internal and external audits and regulatory inspections
Author and review quality documentation including SOPs, investigation reports, and related records
Perform data analysis, trending, and reporting of quality metrics
Collaborate with cross-functional teams to drive corrective and preventive actions (CAPA)
Support continuous improvement initiatives and quality system enhancements

Requirements

Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years' experience in Quality Assurance or Quality Control
Alternatively, an advanced degree with 3+ years of relevant experience
Previous experience within regulated industries such as pharmaceutical, medical device, or biotechnology environments preferred
Experience working with Quality Management Systems, CAPA processes, deviation management, and change control
Strong understanding of investigation techniques, root cause analysis, and corrective action implementation
Experience supporting or hosting internal/external audits and regulatory inspections
Knowledge of statistical analysis, data trending, and quality metrics reporting
Project management experience beneficial
Strong understanding of GMP/GxP regulations and ISO standards including ISO 9001/13485
Knowledge of risk assessment methodologies and continuous improvement tools
Strong technical writing skills for SOPs, investigation reports, and quality documentation
Excellent problem-solving skills and attention to detail
Strong verbal and written communication skills
Ability to collaborate effectively across teams and departments
Comfortable working within manufacturing environments and using PPE where required
Ability to work independently while supporting cross-functional teams

Nice to have

Previous experience within regulated industries such as pharmaceutical, medical device, or biotechnology environments preferred
Project management experience beneficial

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Q&RA Engineer

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