Team Leader, Qc Operation

1 settimana fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

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.

**Responsibilities**:

- to manage GMP data reviewers Team involved in paper and electronic review of analytical testing of raw materials and APIs, intermediates, finished product, stabiity under GMP conditions for QC chemical, biochemical, micro and packaging analysis according to ALCOA+
- to maintain Team training record and support other Teams as required
- to participate in continuous improvement activities and look for further opportuniites to progress the team/department.
- to ensure the continuous updating of the procedures relating to the area of competence in compliance with current regulations (current EU GMP, US GMP)
- to attend recurring meetings to monitor the progress of activities required for batch release.
- to escalate to the Supervisor any critical issues that arise or potentially arise in the future, helping the Supervisor in the "problem solving" process
- to actively participate in internal and external inspections together with the Supervisor as an expert on the topic

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:

- Degree in Chemistry or biochemical or strongly related scientific discipline would be an advantage
- previous experience as analyst/reviewer in chemical/biochemical (ELISA test, HPLC, etc)
- 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.

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