Product Quality Assurance Officer
Randstad
- Dundee
- Temporary
- Full-time
- 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 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