Key Responsibilities
Batch Release & DHR Review: Review Device History Records (DHRs) following ALCOA+ principles to verify compliance with Device Master Records (DMRs), manufacturing procedures, and ERP information. Ensure Quality Events, Non-Conformance Reports (NCRs), and CAPAs are resolved prior to product batch release.
Quality & Compliance: Maintain procedural and regulatory compliance (GxP, GMP, GDP, MDSAP, IVDR).
Process Improvement: Participate in continuous improvement projects, QA standardization activities, and batch review/release documentation revisions.
Collaboration & Communication: Work closely with cross-functional teams, participate in training initiatives, and present quality-related information.
KPI & Metrics Tracking: Collate and communicate key performance indicators (KPIs) to monitor operational quality and analyze trends.
Role Details
Location: Birmingham (Onsite) Employment Type: Full-time (40 hours/week)
Contract Duration: 6 months Shift Pattern: Monday - Friday, 08:30 - 17:00 Pay Rate: £13.94 per hour
Requirements & Qualifications
Education: Minimum 5 GCSEs (Grade 5 or above, or equivalent), including English, Maths, and Science.
Experience: Previous experience in the Medical Device Industry.
Regulatory Knowledge: Sound knowledge of GxP standards, specifically GMP, GDP, MDSAP, and IVDR.
Technical Skills: Proficiency in Microsoft Office (Forms, Teams, SharePoint) and familiarity with quality management systems like MasterControl.
Soft Skills: Excellent oral/written communication, problem-solving skills, strong attention to detail, project management capability, and the ability to prioritize workload.
Other: Ability to complete a standard background check and travel off-site within a 20-mile radius on rare occasions.
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
Salary description
£13.94 - £13.94 per hour