GCP Quality consultants

1 week ago

Slough, United Kingdom MSI Pharma Full time

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from MSI Pharma Senior Recruitment Professional | 29 Years of Senior-Level Staffing Expertise | Empowering CRM Migration & Implementation (Veeva / Salesforce)… Two Contract Opportunities – Quality Management System (QMS) Team 12-month contracts (likely extensions) | Inside IR35 | Hybrid: 2 days per week on-site in Slough A global Biotech organisation is expanding its Quality Management System team and has two openings suited to professionals with around 5-10 years of experience. These roles are hands‑on and operational, ideal for individuals looking to grow, not suitable for managers or directors, as senior profiles will find the work too administrative and process-heavy. Both roles support a large QMS covering more than 500 controlled documents across global clinical operations. 1. Quality Assurance Specialist – Audit & Regulatory Intelligence Focus: Audit hosting, regulatory monitoring, QMS support. Responsibilities Act as host and point of contact during internal audits Liaise with SMEs across clinical operations and quality Support audit planning, preparation and follow up Monitor regulatory intelligence and identify changes impacting processes Contribute to continuous QMS improvements Requirements Approximately 3–6 years of pharma experience in Quality Assurance Hands‑on involvement in GCP audits (GVP / GLP an advantage) Ability to interpret regulatory updates and assess operational impact Strong communication and stakeholder coordination skills 2. SOP Writer – Clinical Operations / Data Management Focus: SOP writing, process documentation, alignment to GCP standards. Responsibilities Write, revise and improve SOPs and process documents Work with clinical operations, GCP and data management SMEs Translate complex processes into clear, structured, compliant documentation Support alignment to updated global guidance Contribute to process harmonisation across the QMS Requirements Approximately 3–6 years of experience in clinical operations or data management Strong GCP knowledge and proven SOP writing ability Comfortable working with multiple stakeholders to capture process detail Excellent organisational and documentation skills The roles will close soon for CV presentations, so please send suitable CVs ASAP. #J-18808-Ljbffr

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