Verified recordMedical Device

Sandra Parker

Lead Quality Assurance Officer Design at Leica Biosystems

Based in Consett, United Kingdom

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Seniority

Other

Department

Other

Location

Consett

Industry

Medical Device

Company size

2.5K

Contact information

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Email

1 credit

s•••••••@leicabiosystems.com

Phone

5 credits

+44 ••• •••• ••••

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Background

About Sandra Parker

Current: Batch Release CAPA, Change Controls, deviations, non conformances, reviewing validation documents. Previous: Document Management for new and ongoing projects. Accoount Co-Ordinator for account for aircraft sealants. Ensuring orders are added into Oracle. Liaising with planning team and Shipping Department to ensure batches are planned in and Orders shipped on time. Previous: Site Lead and part of project team for configuration and implementation of new Company EQMS - Q-Pulse. Highly skilled Quality Professional with experience in a broad spectrum of quality modalities. Experienced in Quality Assurance Systems (6S Auditing, Change Controls, Document Review, CAPA, and understanding & practical application of Regulatory requirements (cGMP, cGLP, ISO 9001:2008 and 9001:2015) & Corporate Standards. Successful roll out and Site Lead for 3 EQMS Document Control Systems (RAPID, Smart Solve and Documentum) Successful roll out, training and Site Lead for 3 Training Databases Successful implementation of the internal labelling system Lean initiatives including 5S support and Kaizans resulting in visual boards Authored and Reviewed Quality Documents including Standard Operating Procedures (SOPs), Management Procedures, and Change Control documentation for site Rebranding I-Procurement Management of Archive System PA/Senior Administrator experience NVQ Level 3 in Business Amin

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