PQA Officer

at  Abbott Laboratories

ABBOTT

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 196 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

REQUIRED QUALIFICATIONS & SKILLS

• SQA Qualification at Nat 5 level or equivalent in Maths, English and a science subject
• Relevant experience within a regulated industry
• 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.

• 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.
• 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.
• Being aware of the policies as set out in the Abbott Employee Handbook.
• Carries out other duties as and when requested by Line and or Department Manager.