Lead QA Technician - Ferentino, Italia - Thermo Fisher Scientific
Descrizione
Job Title:
Lead QA Technician (Investigations Specialist)
Requisition ID:
R
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.
Location/Division Specific Information
Ferentino
How will you make an impact?
No more than 2-3 sentences
What will you do?
Manages Deviations, Investigations relevant to quality issues impacting batches manufactured for clinical and commercial use, by ensuring their completion within the expected timelines;
Manages the CAPAs resulting from quality investigations;
Supports the preparation of periodic quality trends, intended for Management and Corporate visit;
Manages non-conformities in receiving raw materials, active ingredients and GMP materials (incoming defects).
Supports and actively participates in initiatives/projects with Operational Excellence;
Actively participates in all meetings established for new and ongoing projects by taking care quality topics;
Examines and verify and manages Deviations and Investigations with several functions to define the causes and implement the corrective action plan within the timelines established by technical agreements;
Collaborates with DPS (Commercial division) colleagues in organizing technical and management meetings with customers;
Participates in customer visits and quality inspections (Audit);
Generates reports regarding DPS quality events (quarterly monitoring);
Contributes to the achievement of quality objectives for the part under his responsibility, and of the RFT, Deviation Rate, Past due, Ontime closure objectives;
Collaborates with Quality System colleagues in reviewing the SOPs that fall within the scope of the DPS;
Carries out training of staff involved in quality compliance activities for DPS;
Participates in the drafting of Risk Assessment;
Supports and executes negotiation of Quality Technical Agreements with Customers
Degree in Pharmaceutical Biotechnology/ Pharmacy or Chemistry
years of relevant experience in Quality Assurance/Operations
- Preferably experience in a Pharmaceutical or Life Science company
Knowledge, Skills, Abilities
- English (Speaking and writing fluent)
- Italian Fluent
- 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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