Global R&D Quality Assurance Specialist
2 settimane fa
About 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 Documentation Unit Head in harmonizing procedural documents for affiliates and corporate at a global level, meeting regulatory requirements for quality documentation systems.
• Participate in global governance teams as a key user for EDMS, ensuring alignment with regulatory requirements for procedural documentation management.
• Verify EDMS workflows for compliance with internal procedures and manage templates and modules in EDMS.
• Support affiliate and corporate end-users in creating, revising, and withdrawing procedural documents, ensuring their release in EDMS according to company standards.
• Train users on EDMS at the corporate and global level.
• Manage the distribution of SOPs, GLs, and policies at a 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 with senior management.
• Oversee periodic SOP reviews to maintain procedural documentation update, in compliance with quality requirements.
• Properly retrieve, review, and deliver requested documents during audits and/or regulatory inspections, and support Global R&D QA in inspection organizational aspects.
• Support qualified persons in preparing and sending requested documents to regulatory authorities for new implementation or inspection follow-up.
Requirements:
• At least 3 years of experience within R&D in a pharma company, particularly in quality and compliance groups.
• Knowledge of GXP regulations and quality standards.
• Good knowledge of quality documentation management.
• Electronic systems management experience is preferable.
What We Offer:
You would join a dynamic, fast-growing, challenging, and friendly environment. Chiesi invests in continuous training, learning, and development, striving to promote and satisfy development needs, paying particular attention to the quality of the working environment and collective well-being.
-
Global R&D Quality Assurance Specialist
1 settimana 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...
-
Global R&D Quality Assurance Specialist
3 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...
-
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...
-
Senior Global R&D Documentation Specialist
2 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...
-
R&D Documentation Specialist
2 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 Cost Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesThe Global R&D Cost Specialist will be responsible for the administration of cost, investment, and workload planning within R&D systems. This includes collecting information related to functional costs and resources, liaising with relevant functional stakeholders and project managers, and uploading cost and workload planning data to...
-
Senior Documentation Specialist
4 settimane fa
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 implementing Chiesi quality standards in managing Policies,...
-
Global R&D Cost Specialist
6 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob OverviewThe Chiesi Group is seeking a skilled Global R&D Cost Specialist to join our dynamic team. This role will be responsible for administration of cost, investment and workload planning within R&D systems.SalaryWe offer a competitive salary of $80,000 - $110,000 per year, depending on experience.Key ResponsibilitiesCollecting information related to...
-
Global R&D Cost Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pienoJob Title: Global R&D Cost SpecialistChiesi Farmaceutici S.P.A. is seeking a highly skilled Global R&D Cost Specialist to join our team. As a key member of our Research and Development department, you will be responsible for administering costs, investments, and workload planning within our R&D systems.Main Responsibilities:Collecting information related to...
-
Global R&D Cost Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesWe are seeking a skilled professional to join our team as a Global R&D Cost Specialist. In this role, you will be responsible for administering cost, investment, and workload planning within R&D systems.Key Responsibilities:Collecting and analyzing data related to functional costs and resources for planning purposes.Uploading cost and...
-
Quality Assurance Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Thermo Fisher Scientific A tempo pienoQuality Assurance SpecialistAt Thermo Fisher Scientific, we're looking for a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for conducting comprehensive testing and ensuring the quality and reliability of hardware products. You will collaborate with cross-functional teams, track and document defects,...
-
Senior Documentation Specialist for Global R&D
4 settimane fa
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 Financial Planning Specialist
2 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAt Chiesi Group, we are seeking a skilled professional to fill the role of Global R&D Financial Planning Specialist.Main ResponsibilitiesAs a Global R&D Financial Planning Specialist, you will be responsible for:Collecting and analyzing financial data to support R&D planning and budgetingDeveloping and maintaining financial models and forecasts to inform...
-
Global R&D Cost Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pienoAbout the RoleChiesi Farmaceutici is seeking a skilled professional to join our team as a Global R&D Cost Specialist. In this role, you will be responsible for the administration of costs, investment, and workload planning within R&D systems. You will work autonomously or under the coordination of a Cost Resource Coordinator (CRC) and in cooperation with...
-
Global R&D Cost Specialist
2 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout the RoleThe Global R&D Cost Specialist will be responsible for administering cost, investment, and workload planning within R&D systems. This role will involve liaising with function heads, project managers, and other relevant employees to ensure accurate recognition of functional costs and investments. The ideal candidate will possess strong...
-
Quality Assurance Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, we're seeking a Quality Assurance Specialist to join our team. As a key member of our Quality Engineering group, you'll be responsible for conducting comprehensive testing and ensuring the quality and reliability of our hardware products.Key responsibilities include:Collaborating with cross-functional teams to identify and...
-
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...
-
Senior Quality Assurance Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesWe are seeking a Senior Quality Assurance Specialist to manage products/projects related to the respiratory area from a qualitative and analytical perspective. The ideal candidate will collaborate with local and corporate teams, interface with R&D and regulatory functions, and supervise validation activities at Chiesi sites.Key...
-
Global R&D Cost Specialist
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesThe Global R&D Cost Specialist will be responsible for the administration of cost, investment, and workload planning within R&D systems, pertaining to a functional area autonomously or under the coordination of a Cost Resource Coordinator (CRC) and in cooperation with more CRSs, if applicable.The Specialist will liaise mainly with...
-
Quality Assurance Specialist
2 settimane fa
Parma, Emilia-Romagna, Italia Thermo Fisher Scientific A tempo pienoEnhance Quality and Reliability at Thermo Fisher ScientificWe are seeking a skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for conducting comprehensive testing and ensuring the quality and reliability of hardware products.As a Quality Assurance Specialist, you will collaborate with...