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Equipment Validation Compliance Team Leader

Location Monza, モンツァ エ ブリアンツァ県, イタリア Job Id R-01303007 Job Type フルタイム Category 品質・薬事 Remote ハイブリッド
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JOB DESCRIPTION

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.

  • Coordinate with the manager to determine team priorities and ensure the successful implementation of validation document review processes.

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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