Quality Assurance

Description:

We are looking for a Quality Assurance Officer to join the team with our Dundee client. Working as part of the Product Quality Assurance Team, the Product Quality Assurance Officer is primarily responsible for the audit of manufacturing batch records, material inspection and approval.

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.

Working as part of a cross-functional team, attend and participate Tier Review Meetings within a Management Operating System, to facilitate the flow on material through the factory on a daily basis.

Working as part of a cross-functional team, 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.

Taking full accountability for personal workload, ensuring work is completed to a high standard in accordance with site policies, procedures and applicable regulations.

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.

Developing excellent relations with the department team and wider Operations group.

Proposing ideas for new opportunities to improve communication and productivity.

REQUIREMENTS

SQA Qualification at Nat 5 level or equivalent in Maths, English and a science subject and/or

Relevant experience within a regulated industry

SKILLS

Good attention to detail

Excellent timekeeping and organisation skills

Good communication skills, written and spoken

Able to work flexibly and as part of a small team

Experience with an Enterprise Resource Planning System (ERP) preferred

Experience with Electronic Document Management Systems (EDMS) – preferred

Proficient with MS Word, Excel and Power-Point.

Awareness and understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In-vitro Diagnostics preferred, training will be provided