Sr. Process and Systems Optimization Specialist

Há 1 mês

Rio de Janeiro, Brasil Thermo Fisher Scientific Tempo inteiro

**Summarized Purpose**:

- **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 co-ordination with Sub Process Owners (SPOs) or Process Owners (POs)
- **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
- **Audits and Inspections**
- Pre-Inspection Support
- Inspection Readiness Training
- Mock Interview sessions
- Pre-Inspection Doc request and review
- During Inspection support
- Co-host/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 Quality-related 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 medium-scale 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
- **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 multi-disciplinary and/or multi-cultural 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:_
- 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

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