Sr. Process and Systems Optimization Specialist
7 meses atrás
**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 detail
-
Senior Business Optimization Specialist
1 semana atrás
Rio de Janeiro, Rio de Janeiro, Brasil BairesDev Tempo inteiroWe are looking for a proactive and detail-oriented Senior Business Optimization Specialist to join our Development team. This individual will play a key role in evaluating business processes, anticipating requirements, uncovering areas for improvement, and developing and implementing solutions.The ideal candidate will have excellent research and analytic...
-
Specialist Process Engineer
7 meses atrás
Rio de Janeiro, Brasil Equinor Tempo inteiroJob Description We're 20,000 colleagues in more than 30 countries delivering oil, gas, wind and solar power to 170 million people worldwide. Taking on tough energy challenges is our job. Right now, we're facing an enormous task: supplying the world with the energy it needs, while lowering emissions. We're up for the challenge. Are you? The...
-
Process Engineer Specialist
7 meses atrás
Rio de Janeiro, Brasil Equinor Tempo inteiroJob Description We're 20,000 colleagues in more than 30 countries delivering oil, gas, wind and solar power to 170 million people worldwide. Taking on tough energy challenges is our job. Right now, we're facing an enormous task: supplying the world with the energy it needs, while lowering emissions. We're up for the challenge. Are you? The...
-
Sr. Consultant Analyst/Specialist
Há 1 mês
Rio de Janeiro, Brasil Airswift Tempo inteiroAirswift is seeking a Sr. Consultant Analyst/Specialist to work on an outsourced contract in Rio de Janeiro with a major O&G Operator. JOB RESPONSIBILITIESAt this point in time, the Improvement team as part of the Procurement area in Brazil is seeking to allocate resources for the following task: SCM Data Management Responsible meaning: Product owner for the...
-
Process Optimization Consultant Nht Ccr
1 semana atrás
Rio de Janeiro, Brasil buscojobs Brasil Tempo inteiro*At this time, we are only receiving applications from candidates who are currently situated in the Americas. Please make sure your CV is in English only, thank you.Important Notice: By applying through LHR Americas, you are ensuring that your CV will be manually revised by one of our recruiters. If accepted, we will submit it directly to our client’s...
-
Subsea Equipment and Controls Specialist
3 meses atrás
Rio de Janeiro, Brasil Acteon Group Ltd. Tempo inteiroVacancy Name Subsea Equipment and Controls Specialist Vacancy No VN2995 Operating Company 2H Offshore Group Advert 2H Offshore is a global engineering contractor specializing in the design, engineering and integrity management of offshore structures, topsides facilities, subsea components and riser and conductor systems for the offshore oil and gas...
-
Senior Software Optimization Specialist
Há 4 dias
Rio de Janeiro, Rio de Janeiro, Brasil Bairesdev Tempo inteiroBairesDev is a leading technology company with over 15 years of experience delivering cutting-edge solutions to top clients. Our team of 4,000+ experts works remotely on impactful projects worldwide.We're looking for a skilled Senior Software Optimization Specialist to join our Lean Coach team. This role requires a senior developer who is deeply committed to...
-
Performance Improvement Specialist
6 meses atrás
Rio de Janeiro, Brasil Noble Drilling Services Inc. Tempo inteiroThe Performance Improvement Specialist is part of the Operations Performance team within Noble and together with the Performance Systems group works to improve efficiency and consistency in operations and reduce repeat negative occurrences using digital and observational data to identify opportunities for improvement. The Performance Improvement Specialist...
-
Process Optimization Consultant Nht Ccr
Há 5 dias
Região Geográfica Intermediária de Parnaíba, Brasil buscojobs Brasil Tempo inteiroImportant NoticeAt this time, we are only receiving applications from candidates who are currently situated in the Americas. Please make sure your CV is in English only, thank you. By applying through LHR Americas, you are ensuring that your CV will be manually revised by one of our recruiters. If accepted, we will submit it directly to our client’s...
-
Development And Automation Specialist
1 semana atrás
Rio de Janeiro, Brasil buscojobs Brasil Tempo inteiroAbout the Role We are an Amazon marketing agency passionate about helping brands thrive on Seller Central and beyond. We're looking for a tech-savvy E-commerce Automation Specialist to develop cutting-edge systems that streamline operations, optimize Seller Central processes, and create innovative workflows in Airtable using ChatGPT and AI integrations....
-
Senior Procurement Specialist
Há 1 mês
Rio de Janeiro, Brasil inDrive Tempo inteiro, Rio de Janeiro As a Senior Procurement Specialist you will be responsible for overseeing the procurement process and managing the full lifecycle of purchasing activities for goods and services, from sourcing suppliers, negotiation to management of contracts with suppliers **Responsibilities**: - Technically coordinate the purchasing activities within...
-
Electrical Systems Specialist
2 semanas atrás
Rio de Janeiro, Rio de Janeiro, Brasil Tata Consultancy Services Tempo inteiroWe are looking for an Electrical Systems Specialist to join our team at Tata Consultancy Services. As an Electrical Technician, you will play a vital role in ensuring the smooth operation of our IT infrastructure.About the Job:The ideal candidate will have strong problem-solving skills and be able to work effectively in a fast-paced environment. A salary...
-
Rio de Janeiro, Rio de Janeiro, Brasil Osm Thome Tempo inteiroOSM Thome is seeking a highly skilled Electrical Systems Maintenance Specialist for an offshore special purpose vessel in Rio De Janeiro, Brazil. As a key member of our team, you will be responsible for ensuring the smooth operation of all electrical and electronic systems onboard.The estimated salary for this role is around $80,000 to $110,000 per annum,...
-
Finance System Economics Sr. Manager
Há 24 horas
Rio de Janeiro, Brasil The Coca-Cola Company Tempo inteiroAt Coca-Cola, we invest for sustainable growth in the future, and are focused on raising the performance bar to capture opportunities. As a Finance System Economics Sr. Manager, you’ll support the decision making process by providing key insights and valuable analytics based on a thorough understanding of the System economics. **What You’ll Do for...
-
Global Process Owner
4 meses atrás
Rio de Janeiro, Brasil Baker Hughes Tempo inteiro**Global Process Owner - Talent Management and Learning**: **Are you passionate about global processes in the HR function?**: **Do you like to continuously improve processes and implement new technologies?**: **Join our HR Process Solutions and Governance Team** Our HR Process Solutions and Governance Team is responsible for global strategy of end-to-end...
-
Business Intelligence Specialist Upstream and Carbon Insights
3 semanas atrás
Rio de Janeiro, Rio de Janeiro, Brasil Wood Mackenzie Limited Tempo inteiroWe are seeking a skilled Business Intelligence Specialist to join our Upstream and Carbon Management team at Wood Mackenzie Limited. This role will involve working closely with our Research, Data, and Product functions to build, enhance, and maintain the data that underpins our unique understanding of the energy and natural resources sectors.As a Business...
-
Senior Procurement Specialist
2 meses atrás
Rio de Janeiro, Brasil Indriver Tempo inteiroAs a Senior Procurement Specialist, you will be responsible for overseeing the procurement process and managing the full lifecycle of purchasing activities for goods and services, from sourcing suppliers to negotiation and management of contracts with suppliers. ResponsibilitiesTechnically coordinate the purchasing activities within the organization. Proceed...
-
Sr Psg Consultant
Há 23 horas
Rio de Janeiro, Brasil TIBCO Tempo inteiroEnsure customer satisfaction through a successful experience and implementation with TIBCO products. - Assist the Architect to determine scope of work in order to define and communicate the project-level of architecture. - Define end-to-end business process and support systems dialog. - Participate in the development process, individually and/or as part of a...
-
Vaga de HR Specialist
2 meses atrás
Rio de Janeiro, Brasil Catho Online Ltda. - BR - Specialist Tempo inteiroWärtsilä is an innovative technology company known for being a forerunner in the Marine and Energy markets. Every day, we Wärtsilians put our hearts and minds into turning Wärtsilä's purpose of enabling sustainable societies through innovation in technology and services into reality. Our ultimate aim is to provide increased value to both our...
-
Advanced Design Optimization Specialist
2 semanas atrás
Rio de Janeiro, Rio de Janeiro, Brasil TechnipFMC Tempo inteiroAt TechnipFMC, we're seeking a highly skilled Advanced Design Optimization Specialist to join our engineering team. This key role involves developing innovative solutions to meet customer requirements for proposals and projects.Primary Objectives:Orient costs and deadlines towards their targets.This position requires strong analytical and problem-solving...