Sr. Process and Systems Optimization Specialist - Sao Paulo, Brasil - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Sao Paulo, Brasil

há 5 dias

Postado por:

Ana Silva

beBee Recruiter

Descrição

Summarized Purpose:

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Providing R&D Quality support to Affiliate Medical teams

Essential Functions and Other Job Information:

Procedural Support
Review, monitor and approval of controlled process documents for quality, compliance, and commitment gaps, in coordination with Sub Process Owners (SPOs) or Process Owners (POs)

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Compliance Support

Review, assess, monitor and approve process deviations
Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA
Review and approve Quality Issues (QI)
Assist the CAPA owner in performing Root Cause Investigations, review and approve CAPA actions
Monitor CAPA to completion

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Audits and Inspections

Pre-Inspection Support
Inspection Readiness Training
Mock Interview sessions
Pre-Inspection Doc request and review
During Inspection support
Cohost/Host
Inspection Doc Request support
Control Room support
Post-Inspection Support
Lead CAPA plan completion
CAPA Monitoring to Completion
Ensure R&D Quality Management System maintenance in the Affiliate Medical Teams
Support Affiliate Functional Learning Liaison in the maintenance of R&D QMS matrix, inform Functional Learning Liaison (FLL) of new hires and role changes in Affiliate Medical teams that affect R&D QMS activities
Ensure Affiliate Medical Teams have available nominated Affiliate PON representative and CAPA Functional Approver
Support Affiliate Medical Teams in the management of Medical GxP vendors
First point of contact for Affiliate Medical teams for R&D Qualityrelated questions
Assist Affiliate Medical teams with R&D Governance meetings and reports
Serve as overflow support for large scale global audits and documentation requests, when needed
Monitor KQI/KPI's at the affiliate level related to these Quality activities

Additional Responsibilities**- Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements.

Develops varied support materials, presentations, and/or tools to support department's remit and strategies.
Leads small to mediumscale process improvement initiatives.
Develops process improvement processes and solutions.
Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs.
May review, assess and update procedural documents for overall compliance with current processes.
Performs special projects, assignments and administrative tasks per business needs.
Provides training and guidance to junior team members.

Job Knowldge

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

This job is the fully qualified, career-oriented, journey-level position.

Education and Experience:

Degree in
Life Sciences or Engineering:
Minimum 2 years of experience in CAPA management and Quality Audit/Inspection support activities

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Fluent in English - read, write, speak. Fluency in additional languages (such as Spanish, Portuguese, Chinese, Japanese etc.).

Experience in TrackWise or other electronic Quality Management Systems (eQMS)
Experience in electronic Document Management System (eDMS)

Knowledge, Skills and Abilities:

Thorough understanding of procedural documents
Strong understanding of process improvement fundamentals
Solid investigative and analytical skills
Strong negotiation skills
Thorough understanding of clinical management technology and systems, and strong computer skills
Effective judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
Strong interpersonal skills and problem solving ability
Capable of directing and promoting teamwork in a multidisciplinary and/or multicultural team setting
Strong attention to detail
Thorough understanding of regulatory guidelines and directives
Strong creative and critical thinking skills
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment/requirements for this role:
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Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more deta