- Experience in pharmaceutical industries
- Multi-year experience in Quality Control
- 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
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Team Leader, QC PDS AD - Ferentino, Italia - Thermo Fisher Scientific
Descrizione
You will supervise and coordinate analytical activities through effective/efficient planning and progress control, to meet OTD/RFT (timely delivery / right first time) and support client in achieving their requests.
What will you do?
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
How will you get here?
Education
Degree in CTF, Chemistry, Biology or other similar fields
Diploma Chemical/Laboratory technician certificate
Experience
Knowledge, Skills, Abilities
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