Global R&D QA, Senior Documentation Specialist
4 settimane fa
Date: 30 Sep 2024
Department: Global R&D Quality Assurance
Team: Quality
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for
PurposeThe Senior Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at global level in the procedural documentation management, Electronic Documentation Management System (EDMS) configuration and to support the implementation of Chiesi quality standards in managing Policies, Guidelines, SOPs keeping them aligned to GXP (GCP/GLP/GMP/GDP/MD/GVP) requirements.
Main ResponsibilitiesThe person will:
- Support the Global R&D Training and Documentation Unit Head in the harmonization of procedural documents for affiliates and corporate at global level to meet regulatory requirements of Quality documentation system.
- Take part at global level of governance teams as key user on EDMS to keep it aligned to the regulatory requirements for procedural documentation management.
- Verify the workflows within the EDMS for compliance with internal procedures (Quality Check) and manage the Templates and Modules in EDMS.
- Support Affiliate and corporate end users on creation, revision, withdrawal of procedural documents, ensuring their release in EDMS according to the company standards.
- Train the users on EDMS at corporate and global level.
- Manage the distribution of SOP/GL/Policies at global level (Corporate departments and Affiliates) and to external Providers (CROs and Pharmacovigilance Service Providers).
- Extract and process Quality Metrics and KPIs related to procedural documentation for sharing them with Senior management.
- Oversee SOPs periodical review to keep procedural documentation update, in compliance with quality requirements.
- Properly retrieve, review and deliver in timely manner the requested documents during audits and/or regulatory inspections and Support Global R&D QA in the inspection organizational aspects.
- Support Qualified Persons in the preparation and sending requested documents to regulatory authorities (AIFA) for new implementation or inspection follow-up.
At least 3 years experience within R&D in a pharma company, particularly in Quality & compliance groups.
- Knowledge of GXP Regulations and Quality Standards.
- Good knowledge of the quality documentation management.
- Electronic systems management experience is preferable.
Master’s degree in life sciences (e.g. Pharmaceutical Chemistry, Biology etc.)
LanguagesFluent in written and oral English.
Technical Skills- Good computer skills, proficient with Microsoft Office applications/software.
- Previous experience in EDMS use is preferable.
- Planning and organizational skills
- Problem solving
- Strategic thinking
- Goal orientation
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
#J-18808-Ljbffr-
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe Senior Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at global level in the procedural documentation management, Electronic Documentation Management System (EDMS) configuration and to support the implementation of Chiesi quality standards in managing Policies, Guidelines, SOPs keeping...
-
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The Senior Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at global level in the procedural documentation management, Electronic Documentation Management System (EDMS) configuration and to support the implementation of Chiesi quality standards in managing Policies,...
-
Global R&D Qa, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoGlobal R&D QA, Senior Documentation SpecialistDate: 30 Sep 2024Department: Global R&D Quality AssuranceTeam: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with...
-
Global R&D Qa, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024Department: Global R&D Quality AssuranceTeam: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees. To achieve its...
-
Global R&D Qa, Senior Documentation Specialist
2 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024 Department: Global R&D Quality Assurance Team: Quality Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees. To...
-
Global R&D QA, Senior Documentation Specialist
3 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024 Department: Global R&D Quality Assurance Team: Quality Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees. To...
-
R&D Documentation Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoR&D Documentation Specialist Job SummaryChiesi Group is seeking a highly skilled R&D Documentation Specialist to support the global R&D functions and affiliates in procedural documentation management. The successful candidate will work closely with the Global R&D Training and Documentation Unit Head to harmonize procedural documents for affiliates and...
-
Global R&D QA, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024Department: Global R&D Quality AssuranceTeam: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees. To achieve its...
-
Global R&D QA, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024Department: Global R&D Quality AssuranceTeam: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees. To achieve its...
-
Senior Global R&D Documentation Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob Description:The Senior Global R&D Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at a global level in procedural documentation management, EDMS configuration, and implementing Chiesi quality standards for managing Policies, Guidelines, SOPs, aligning them to GXP requirements.Main Responsibilities:Support the Global...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoSenior Documentation and Compliance SpecialistWe are seeking a skilled Senior Documentation and Compliance Specialist to join our Chiesi Corporate R&D Functions at a global level.About the RoleThis is a challenging opportunity for a motivated professional with excellent documentation management skills and knowledge of GXP Regulations. The successful...
-
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pienoAbout the JobChiesi Farmaceutici S.P.A. is seeking a Senior Documentation Specialist to support the Global R&D Quality Assurance team in procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and the implementation of Chiesi quality standards. The successful candidate will work closely with the Global RD...
-
Global R&D Quality Assurance Specialist
2 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pienoWe are looking for a talented Senior Documentation Specialist to support our Global R&D Functions and Affiliates at a global level in procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and implementing Chiesi quality standards in managing Policies, Guidelines, SOPs, keeping them aligned to GXP...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob SummaryWe are seeking a highly skilled Senior Documentation Specialist to support our Global R&D Functions and Affiliates at a global level. The successful candidate will be responsible for procedural documentation management, Electronic Documentation Management System (EDMS) configuration, and ensuring compliance with Chiesi quality standards.Main...
-
Global R&D Qa, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoGlobal RD QA, Senior Documentation SpecialistDate: 30 Sep 2024Department: Global RD Quality AssuranceTeam: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more...
-
Global R&D Quality Assurance Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoThe Senior Documentation Specialist will play a key role in supporting Chiesi Corporate R&D Functions and Affiliates at a global level in procedural documentation management and Electronic Documentation Management System (EDMS) configuration.Main Responsibilities:Support the Global R&D Training and Documentation Unit Head in the harmonization of procedural...
-
Global R&D Quality Assurance Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout the Role:The Senior Documentation Specialist will support Chiesi Corporate R&D Functions and Affiliates at a global level in procedural documentation management, EDMS configuration, and implementing quality standards for managing policies, guidelines, and SOPs, aligned to GXP requirements.Main Responsibilities:• Support the Global R&D Training and...
-
Global R&D Qa, Senior Documentation Specialist
4 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 30 Sep 2024 Department: Global RD Quality Assurance Team: Quality Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees.To achieve its...
-
Senior R&D Manager Bakery
4 settimane fa
Parma, Emilia-Romagna, Italia PURATOS A tempo pienoSenior R&D Manager BakeryAs a key member of the R&D Country Team, the Senior R&D Manager Bakery plays a crucial role in driving innovation and growth in the Bakery segment. Working closely with the R&D Country Manager and Sales & Marketing team, this individual is responsible for delivering exceptional technical support to customers, developing and adapting...
-
Senior R&D Manager Bakery
6 mesi fa
Parma, Italia Puratos A tempo pienoPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: As a member of R&D Country Team, the Senior R&D Manager Bakery works closely to R&D Country Manager and Sales & Marketing team to offer the best technical support to customers, developing and adapting Bakery products according to their needs. Core responsibilities...
