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Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description: MAIN SCOPE OF THE POSITION / RESPONSIBILITIES: The Manufacturing Process Expert will serve as a sophisticated root cause analysis expert in support of a cross-functional team that is focused on problem-solving and continuous improvement for the site. The investigation team is a key part of the Technical Unit organization. It is focused on driving quality excellence, prevention of error and deviations, continuous improvement, and effective problem-solving. The Manufacturing Process Expert is responsible for facilitating and performing advanced root cause analysis to solve complicated technical problems.
ASSIGNMENTS, SPECIFIC / PRIMARY ACTIVITIES: Investigations:Management of deviations, in teamwork with cross-functional teams.Investigation plan definition:Lead and/or complete the Root Cause Analysis for deviation events and guide the definition of CAPA with a cross-functional team.Implement technical analysis within and outside the Technical Unit.Lead cross-functional investigation teams inside and outside the Technical Unit.Applies knowledge of manufacturing processes and investigation skills to identify and resolve manufacturing issues, while driving continuous improvement in process operations.Technical process Acknowledgment / Production:Supports Manufacturing in the implementation of Corrective and Preventive actions (CAPA) in collaboration with Quality Specialist (QS).Proactively identify and mitigate risks.Sharing of lessons learned during the Technical Unit huddles.Audit:Applies manufacturing process knowledge and investigation skills when conducting client and Regulatory audits for assigned deviations.Approach / Important Metric:Achieve "zero past due" objectives in Quality (CAPA, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTIF (On-Time In Full) objectives for document submission to the client and lot release.RELATIONS: Internal: All functions and seniority levels, Direct report of Quality Operations Manufacturing Supervisor, Collaboration with Quality Specialist of the TU.
External: Corporate functions, Employees from other Thermo Fisher Scientific sites, Customers, Consulting firms, Suppliers.
REQUIREMENTS: Degree in Chemistry / CTF / Biological Sciences or similar fields.
Desirable: Experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturing. Excellent knowledge of GMP and national/international regulations.
Technical competences: Ability to function in a fast-paced, multifaceted environment with multiple priorities simultaneously.Strong interpersonal and communications skills; written and oral.Thorough knowledge of cGMP.Must be skilled in meetings and interviews to elicit technical details from subject matter experts.Must be skilled in the use of a personal computer and related software applications; Trackwise helpful.Ability to write, handle, and review GMP documentation (Deviations, CAPAs…) and understanding of main quality indicators.Knowledge of injectable sterile process manufacturing.Desirable: Solid understanding of root cause analysis tools; TapRoot preferred.Strong planning, organization, and multitasking skills.Professional Experience: Experience within manufacturing industries.
Fluency in English and Italian.
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