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Analytical Development GMP Specialist

2 mesi fa

Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
{"title": "PDS Analytical Development GMP Scientist", "description": "Make a Real Impact

At Thermo Fisher Scientific, you'll be part of a team that's changing the world. As a PDS Analytical Development GMP Scientist, you'll play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Ensure the execution and supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements.
  • Support analysts in problem-solving for analytical activities relating to API / DS and finished products (Release and Stability).
  • Draw up analytical specifications, study protocols, and reports, analytical methods, and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
  • Coordinate customer management to maintain a high level of customer satisfaction and complete required activities on schedule.
  • Participate in calls/meetings with customers to support discussion on technical topics for their area of expertise.
  • Identify requirements for analytical technology transfer from customers and ensure accurate and effective transfer to laboratories.
  • Handle laboratory investigations (Out of Specification and Deviation Reports).
Requirements
  • Degree in CTF, Chemistry, Biology, or other similar fields.
  • Diploma Chemical/Laboratory technician certificate.
  • Experience in pharmaceutical industries.
  • Multi-year experience in Quality Control.
  • Knowledge of main techniques of chemical-physical and biochemical analysis and validation of analytical methods.
  • Knowledge of GMP and national/international regulations.
  • Good problem-solving abilities.
  • Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager).

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.", "company": "Thermo Fisher Scientific", "location": "Ferentino, Italy"}