Associate Principal QA Specialist, QA Technical Operations Company: Global Pharmaceutical Manufacturing Organisation
Location: Slough, UK - Hybrid
Manage and address GMP issues through QMS processes, site governance, and senior QA leadership.
Serve as a GMP subject matter expert (SME), implementing, managing, and enforcing quality processes on-site.
Assist Senior QA leadership in driving continuous improvement and ensuring ‘fitness for purpose’, maintaining compliance with regulatory authorities, global quality standards, and customer expectations.
Provide hands-on review, approval, and support to key business partners for managing quality records, including Deviations, CAPAs, Change Controls, Investigations, and OOSs.
Apply knowledge of GMP and quality processes within functional areas to manage and escalate significant compliance issues through the site QMS processes, including deviations and CAPAs.
Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality culture.
Actively contribute to PQS process improvement initiatives and projects.
Provide QA SME support at departmental Local Quality Councils and project meetings.
Provide QA SME support for manufacturing during out-of-hours.
Previous experience as a QA approver of Deviations, CAPAs, Change Controls, OOSs
Scientific Degree Required
Strong quality-focused mindset.
Apply now for immediate consideration or contact Maria Tsalpatourou at mtsalpatourou@planet-pharma.Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.