QA Consultant
Company Overview
Robosol has been working with SMB companies from Pharmaceutical, Retail, Packaging, Textile and Engineering sectors implementing Microsoft Dynamics Nav, CRM and other Microsoft solutions in GB and other parts of the world.
Summary
Join Robosol Software UK Limited as a QA Consultant in GB to contribute to delivering high\-quality software solutions for diverse industries. This role is vital in ensuring our products meet the highest standards of quality and reliability from our base in GB.
In this role, you will support the implementation, validation, and ongoing operation of QMS platforms for our regulated industry clients spanning pharmaceuticals, veterinary medicines, biotech, and food and drinks manufacturing.
You will be equally comfortable configuring and validating a QMS platform as you are supporting clients through day\-to\-day quality operations and compliance workflows. You will work closely with our CSV and ERP consultants to deliver end\-to\-end quality solutions that meet MHRA, FDA, and EU GMP expectations.
Key Responsibilities:
- Implement and configure QMS platform for clients in regulated industries.
- Validate QMS platforms in line with GAMP 5, EU GMP Annex 11, and 21 CFR Part 11 requirements, producing required documentation.
- Support clients with quality operations across core QMS modules including Change Control, Deviations, CAPA, OOS/OOT investigations, Complaints, Document Management, and Training Records.
- Develop and maintain QMS policies, SOPs, and validation documentation.
- Collaborate with client QA, IT, and operational teams to ensure platform compliance with regulatory requirements.
- Conduct risk assessments and manage validation issues throughout the platform lifecycle.
- Provide training and guidance to client staff on QMS platform use and GxP best practices.
- Bachelor's degree in Pharmacy, Life Sciences, Computer Science, or a related field.
- Proven experience (3\+ years) working with a QMS platform (e.g. Veeva Vault QMS, MasterControl, ETQ, Pilgrim SmartSolve, or equivalent) in a regulated industry setting.
- Strong knowledge of regulatory requirements including EU GMP Annex 11, GAMP 5, FDA 21 CFR Part 11, and ICH Q10\.
- Hands\-on experience writing and reviewing validation deliverables (URS, FDD, IQ, OQ, PQ, RTM, VSR).
- Familiarity with core pharmaceutical quality processes: Change Control, CAPA, Deviations, Document Control, and Training Management.
- Strong analytical, problem\-solving, and communication skills.
- Ability to manage multiple client engagements independently and as part of a team.
- Detail\-oriented with a genuine commitment to quality and compliance.
Benefits:
- Casual dress
- Company events
- On\-site parking
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