Job Reference: J5634724
Updated On: 08/04/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a eQMS Quality Systems Specialist to join a leading pharmaceutical company based in the Middlesex area. As the eQMS Quality Systems Specialist you will be responsible for administration of the companies Quality Management System (eQMS [TrackWise]). You will ensure the quality system remains fit for purpose and that staff across the entire business can use the this to enable compliance.
Key Duties and Responsibilities
Your duties as the eQMS Quality Systems Specialist will be varied however the key duties and responsibilities are as follows:
1. Management of the eQMS system (TrackWise) and providing training and support to all staff on this system.
2. You will manage eQMS administration and update and maintain this to meet changing business and regulatory requirements including metric reporting. You will also be responsible for managing the eQMS business system administration.
3. As the eQMS Quality Systems Specialist you will Coordinate eQMS Local Administrator SME activities to ensure delivery of eQMS strategy and consistency across the company.
4. You will Support regulatory Inspections/Audits for all and document releases including preparation, facilitation and response support concerning the QMS.
To be successful in your application to this exciting opportunity as the eQMS Quality Systems Specialist we are looking to identify the following on your profile and past history:
1. Strong knowledge and application of the requirements for Computer Systems Validation including the regulatory requirements (21.CFR.11) for use of electronic signatures and GAMP regulations
2. Proven industry experience in the pharmaceutical and/or medical device industry.
3. A working knowledge and practical experience with implementing and managing/maintaining electronic QMS with an understanding of regulatory requirements.
Key Words: Quality Assurance | Quality Manager | QA | CSV | GAMP | Annex | Quality | Computer | QMS | Quality Systems | GMP | QA | Pharmaceuticals | Biopharmaceuticals | Life Sciences | eQMS | trackwise | validation | Medical device | SME
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