Equipment Validation Compliance Team Leader Monza

Equipment Validation Compliance Team Leader
Monza
Lombardia, Monza

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Job Description Purpose of Role/Responsibility: Lead the Equipment Validation Compliance Team at Thermo Fisher Scientific, ensuring flawless processes and world-class standards.

Lead an ambitious team, driving excellence and compliance in a dynamic and collaborative environment.

Support manager in the team coordination for the review of equipment validation documents.

Primary Activities: Lead and support your team in achieving outstanding results and maintaining high standards of quality and compliance. Analysis of Technical Documentation: Conduct detailed analyses of technical documents to verify compliance with regulatory standards and company procedures. Ensure the review of the technical documentation for equipment qualification (IQ-OQ-PQ protocols and reports), in compliance with current regulations (GMP standards, FDA, etc. )

and company procedures.

Coordinate the stringent review of qualification protocols and reports, ensuring alignment with industry regulations and internal guidelines. Audit: Assist the manager in preparing for and attending audits by external bodies, providing necessary documentation and information to demonstrate compliance and excellence. Quality: Maintain and improve quality standards by verifying and reviewing procedures, ensuring strict adherence to company and regulatory requirements. Employee Management: Lead the team by setting clear goals, recognizing achievements, and identifying training and development needs to foster a motivated and high-performing workforce. Requirements and Qualifications: Bachelor's degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, or Chemical Engineering. In-depth knowledge of cGMP, pharmaceutical processes, equipment, and utilities validation, particularly in bioprocessing and mRNA requirements. Professional Experience: Minimum of 5 years' experience in equipment and utilities validation with a proven track record in a sterile pharmaceutical environment. Languages: Proficient in English. Personality: Strong teamwork orientation. Excellent technical documentation skills. High attention to quality and detail. Strong organizational and management capabilities. Desirable: Technical/engineering expertise in production facilities for lyophilized drugs, sterile liquids, or oral solids. Experience in personnel management.

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