We are recruiting for a Product Quality Assurance Officer to work as part of the Product Quality Assurance Team being primarily responsible for the audit of manufacturing batch records, material inspection and approval.
The successful candidate will be joining a global rapid diagnostics testing business based in Dundee, working 37.5 hours per week on a bi-weekly rotating shift pattern across Mon-Fri 06:00-14:00 and 14:00-22:00.
This position is offered as a contract opportunity for 12 months initially, with the potential to be extended or turn into a permanent position.
Responsibilities:
- Compliance Audit of Manufacturing Records; Rare Reagent, Buffers, Bulk Formulation, Dispensing and Kit Pack.
- Compliance audit of QC test records.
- Material inspection versus specification; sub-assemblies, intermediates and finished kits.
- Material control within ERP System; approval, reject, rework, quarantine.
- Approve Quarantine removal and rework operations.
- Performing Archiving activities for Device History Records per record retention policy to maintain both on-site and off-site records archive.
- Participate in Tier Review Meetings within a Management Operating System, to facilitate the flow on material through the factory on a daily basis.
- Perform document control activities; coordination of the document introduction, amendment and obsolescent process within an electronic document management system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval.
- Perform CAPA Coordinator activities; coordination Quality Incidents and Deviations within a Quality Management System (Agile.
- Proactively contributing to continuous improvement initiatives and other general housekeeping duties.
- Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
- Proposing ideas for new opportunities to improve communication and productivity.
Experience & Qualifications:
- Experience the life sciences or similarly regulated industry (In-vitro Diagnostics preferred)
- A practical understanding of record audit and material approval processes per ISO 13485:2106 for the Design and Manufacture of In-vitro Diagnostics
- Experience with an Enterprise Resource Planning System (ERP)
- Experience with Electronic Document Management Systems (EDMS)
- Experience with CAPA systems - Agile preferred
- Proficient with MS Word, Excel and Power-Point
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.
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