Investigation & Client Quality Specialist
2 settimane fa
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Thermo Fisher Scientific to make a positive impact globally and help solve tough challenges like protecting the environment and finding cures for cancer.
The Investigation & Client Quality Specialist:
Handles company functions to define the causes and implement the corrective action plan within the timeframes set out in technical agreements;
Verifies, over time, the efficiency of corrective actions;
Collaborates with colleagues in coordinating technical and management meetings with customers;
Participates in customer visits and quality inspections (Audits) and internal and regulatory body quality inspections;
Generates reports on quality events;
Aims to achieve quality objectives for the part of their competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives;
Supplies to the achievement of Business/customer objectives;
Collaborates with Compliance colleagues in reviewing and drafting the Quality System SOPs that fall within the scope of the Quality Unit to which they belong;
Provides customers with support via TLC and e-mail, promptly responding to quality questions; participates in the drafting of FMEAs;
Handles the drafting, archiving, and distribution of controlled company documentation;
Trains personnel involved in PDS/DPS quality activities;
In accordance with the instructions and scheduling of activities by the manager, drafts QATs and negotiates them with Customers, site QPs, and the legal team;
Covers the role of SME and QO contact for assigned projects, representing the quality figure of reference and support for Customers and internal departments in order to guarantee the success of projects and the manufacturing/disposition of GMP batches;
Supports the team and other functions in ensuring full support for Readiness and BUs processes.
Requirements:
Degree in CTF, Biotechnology, Pharmacy, Chemical Engineering, Management Engineering or similar.
Relevant experience in similar roles in the pharmaceutical sector.
Proficiency in English, both written and oral.
Post-degree courses in QA will be considered a plus.
Knowledge, Skills, Abilities:
GMP knowledge
Knowledge of main IT software
Leadership
Independence in handling tasks
Ability to work in a team
At our company, each one of our 70,000 outstanding minds has a unique story to tell. Join us and let's reach our mission—enabling our customers to make the world healthier, cleaner, and safer
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