Team Leader, QC PDS AD & GMP

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of Thermo Fisher Scientific, you’ll have the chance to actively performs significant and important work, like helping customers in finding innovative life-saving treatments for severe diseases, protecting the environment or making sure our food is safe. Your work will have real-world implication and impact, and you’ll be supported in achieving your career goals. You will join a team with wide-ranging strengths!

EDUCATION

Degree in CTF, Chemistry, Biology or other similar fields
Diploma Chemical/Laboratory technician certificate

EXPERIENCE

• Experience in pharmaceutical industries
• Multi-year experience in Quality Control

KNOWLEDGE, SKILLS, ABILITIES

• Knowledge of the principal techniques of chemical-physical and biochemical analysis and validation of analytical methods
• Knowledge of GMP and national/international regulations
• Good problem-solving abilities and Leadership experience.
• Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager)
• Be prepared to work with conflicting priorities, under time constraints and in a dynamic environment
  At Thermo Fisher Scientific, each one of our 70,000 outstanding minds has a unique story to tell. Join us and give yourself the opportunity to collaborate with us in our important mission—enabling our customers to make the world healthier, cleaner and safer

Ensures both the coordination, execution and constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts in problems solving.
Supports scientists in drafting analytical specifications, study protocols/reports and analytical methods. Writes and review SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
Coordinates along with the Supervisor and Manager the customer’s management with the aim of maintaining a high level of customer happiness and completing the required activities on schedule
Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise
Collaborates with the Supervisor to identify the requirements for analytical technology transfer from customers, then ensuring the accurate and effective transfer to the laboratories
Collaborates with the Supervisor in handling laboratory investigations (Out of Specification and Deviation Reports)
Ensure the execution of Method Development and/or Method Validation for assigned projects
Ensure effective management of the Team and resources assigned