QC NPI QC Compliance

2 mesi fa

Monza, Lombardia, Italia ThermoFisher Scientific A tempo pieno

Work Schedule

Other

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Monza site is an outstanding pharmaceutical contract manufacturing and development facility, specialized in aseptic injectable drugs, with a growing focus on biologics. Joining more than 1800 colleagues on site, the selected candidate will experience an excellent, international, and fast-growing environment. With revenues exceeding $24 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world.

Responsibilities:


• Manage the documentation, reordering and correct storage of the Reference Standards and reagents of the DPS laboratory;


• Perform queries, with the frequency established by the procedures, to guarantee the availability of Std/Reagents from the DPS chemical laboratory;


• Ensure the resolution of problems with suppliers and those presented by analysts;


• Collaborate with the TLs of the DPS Chemical Laboratory to ensure the correct management of Reference Standards and DPS laboratory reagents


• Ensure documentation verification of standards/reagents for DPS Audits (Regulatory/Corporate and Customer Audits).


• Contribute to the successful outcome of regulatory and customer inspections by responding directly to requests made in the field and during the review of the required documentation in the room.


• Guarantee the correct and timely movement of the material, temporarily stored in the warehouse awaiting registration in the system, from the warehouse to the laboratory


• Ensure verification of adherence to the Pharmacopoeias and evaluation in case of updates relating to the job performed


• Update department-specific procedures


• Ensure management of safety data sheet and carcinogenic reagent deadlines


• Participate in updating the department's SOPs at the request of the manager.


• Ensure that training packages are kept up to date with those assigned to the role.

EH&S:

  • Understand emergency procedures and comply with safe systems of work.
  • ensure compliance with environmental
  • prompt reporting any near misses and breaches of rules

Minimum requirement:

  • high school or degree in scientific discipline would be an advantage
  • ability to work under critical timelines
  • effective communication skills at all internal and external levels
  • excellent attention to detail
  • excellent organization skills

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.

Join us

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


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