Beschreibung

In this role, you will ensure compliance and excellence in qualification and validation activities. You will collaborate with various teams to manage documentation, support audits, and refine validation strategies while staying updated on industry trends.

Anforderungen

• •Master’s degree or equivalent in Biology, Chemistry, Pharmacy, or natural science
• •Documented training in GMP regulations, Quality Management Systems, equipment qualification, and method validation
• •Minimum 3 years of professional experience in equipment qualification and method validation
• •Strong knowledge of GMP and qualification/validation guidelines
• •Familiarity with risk assessment tools and compliance of computerized systems
• •Excellent documentation skills with high attention to detail and accuracy
• •Exceptional analytical and problem-solving abilities
• •Excellent communication and interpersonal skills, with fluency in English
• •2-5 years of professional experience

Aufgaben

• •Compile, review, and approve instrument qualification documentation
• •Release equipment for GMP use after successful qualification
• •Compile, review, and approve risk assessments for equipment qualification
• •Ensure qualification and validation documentation meets internal SOPs and regulatory standards
• •Support management of equipment-related changes, deviations, CAPAs, SST failures, risk assessments, and OOS cases
• •Compile, review, and approve analytical method validation and verification documentation
• •Provide validation support for technology transfers and process changes
• •Collaborate with analytical teams on method validation projects for compliant outcomes
• •Support the GMP analytical team in defining validation strategies and managing analytical methods' lifecycle
• •Assess validation needs during technology transfers or new process introductions
• •Monitor industry trends and regulatory updates to enhance validation strategies
• •Provide technical guidance and training on validation requirements and procedures
• •Support internal and external audits and authority inspections for compliance readiness

Tools & Technologien