6 months ago

Lead Expert Validation, Dalry

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Source: Company careers pageValidated by: Fursa AI

Last checked: 1 hour agoStatus: Live

Job Summary

Lead the site quality department's validation program in Dalry, coordinating cGMP validation activities for equipment, processes, packaging lines and facilities. Ensure validated status across utilities and processes, author and maintain validation documentation, and support production with validation activities. Drive risk management, statistical monitoring, audits, and CAPA closure, collaborating with corporate validation teams to ensure compliance and continuous improvement.

Location: United Kingdom

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Key Responsibilities

•Provide leadership within the Quality Department for the management and coordination of site cGMP validation activities.
•Support validation during design, installation and commissioning of new equipment, processes, packaging lines and facilities.
•Maintain validated status of site facilities, equipment, processes, CSV and utilities in line with local and corporate procedures and regulatory guidance.
•Author, review, execute and maintain validation documentation including the Validation Master Plan and Site Validation Strategy.
•Coordinate with production and external audits, including customer and regulatory inspections, and manage CAPA related to non-conformances.

Key Requirements

•A degree in a relevant science or engineering discipline.
•Minimum 5 years of validation and qualification experience in a cGMP regulated life science industry (pharmaceutical, API or biotech).
•Excellent communication and organizational skills, with the ability to work independently and within cross-functional teams.
•Experience managing validation documentation including Validation Master Plan and Site Validation Strategy.
•Proficiency with quality risk management tools (e.g., FMEA) and statistical techniques.

Experience:5+ yearsPharmaceuticalBiotechLife sciences

Education:Bachelor's

Skills:CommunicationOrganizationCross-functional collaborationLeadership

Tech Stack:FMEAStatisticsValidationCSVCAPA

Company Brief

DSM

Industry: Chemical Manufacturing

Website

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DSM