Quality & Regulatory Affairs (Q&RA) Engineer
Location: Remote (with travel to Basingstoke approximately once per month)
Contract Length: 9 months (initial contract, potential for extension)
Hours: Full-time, 40 hours per week
Pay Rate: £20-23.50 per hour (Equivalent to £48,100 per annum)
Start Date: ASAP
About the Role
We are looking for an experienced Quality Engineer to join our team on an initial 9‑month contract. This role offers a fantastic balance of remote working alongside a high‑performing global team, with just an occasional requirement to attend onsite meetings in Basingstoke (typically once a month).
You will be responsible for ensuring quality compliance across our operations, providing essential oversight through detailed documentation reviews, process monitoring, and cross‑functional collaboration.
Key Responsibilities
* Support and maintain compliance with GMP/GxP, ISO standards, and regulatory requirements.
* Investigate quality events, deviations, and lead root cause analysis efforts.
* Manage and support change control activities and CAPA processes.
* Conduct and support both internal and external audits, as well as regulatory inspections.
* Author, review, and update quality documentation, including SOPs and investigation reports.
* Perform data analysis, trending, and reporting on key quality metrics.
* Collaborate with cross‑functional teams to drive corrective actions and continuous improvement initiatives.
What We Are Looking For
* Education: A Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field.
* Experience: 5+ years of experience in quality assurance/quality control within a regulated industry (pharmaceutical, medical device, or biotech preferred). Candidates with an advanced degree and 3+ years of experience will also be considered.
* Systems: Hands‑on experience with Quality Management Systems (e.g., MasterControl, TrackWise, or similar Document Control Systems).
* Skills: Strong technical writing skills, proven expertise in root cause analysis, and proficiency in statistical analysis/data trending.
* Standards: Solid knowledge of GMP/GxP regulations and ISO standards (such as ISO 9001 or ISO 13485).
Apply today!
Equal Opportunity Statement
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
#J-18808-Ljbffr