Shire Jobs

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 teamworks with cross functional team

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 team 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

Give to achieving "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 eliciting 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

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.