Quality & Validation Systems Specialist (Pharma)
4 semanas atrás
Join a Market Leader
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to:
Defines and implements procedures and processes to assure that Hovione Computerized systems are fit for purpose and comply with applicable quality and data integrity standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and data integrity requirements to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying best practices.
Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH) Participate in project teams that require expertise in Computerized Systems. Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality Implement the defined policies for Computerized Systems life cycle Management Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle Implement data integrity principles during the Computerized System life cycle, as defined Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Validation of Computerized Systems and other validation/qualification documents Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state Review/approve documentation regarding Computerized Systems data integrity and its life cycle management Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems. Support internal, external/ customers’ audits and health authorities’ inspections. Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner Propose improvements to the area as appropriate and solve problems Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
We are looking to recruit a Candidate:
BSc / BEng, MSc / MEng, PhD in chemical engineering or equivalent. Min 3-5 years’ relevant experience in Computerized Systems Validation/Testing and/or Data Integrity within the pharmaceutical industry (GMP/GAMP experience is mandatory) Experience in technical manufacturing support. Strong understanding and knowledge of: Software testing Quality systems and validation principles Computerized Systems Validation Data Integrity Principles GAMP 5 Guide: Compliant GxP Computerized Systems, cGMP, ICH and ISO guidelines Risk Assessment applied to Computerized Systems Life Cycle Result driven, team player, able to deal with multiple projects/tasks. Ability to interact with and be part of multi-disciplinary teams.-
Qualification and Validation – Assistant
Há 6 dias
Lisbon, Portugal Recipharm Tempo inteiroGenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies. GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development,...
-
Software Validation Lead
2 meses atrás
Lisbon, Portugal Faurecia Tempo inteiroJob Description New trends and expectations are reshaping the automotive industry. Inspired by the exciting new challenges associated with this revolution, Faurecia anticipates the future of mobility developing cutting-edge solutions for smart life on board and sustainable mobility. If you’re willing to contribute and create value for tomorrow’s...
-
Computerized Systems Trainee
Há 8 horas
Lisbon, Portugal Hovione Tempo inteiroJoin a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...
-
Operations Quality Specialist
Há 7 dias
Lisbon, Portugal AstraZeneca Tempo inteiroMarketing Company Operations Quality Specialist Introduction to Role: Join our team as a Quality Specialist, within the global organization Marketing Company Operations Quality (MCOQ), where you'll manage all required activities, tasks, and processes to ensure compliance with Good Distribution Practices of Medicinal Products for Human Use (GDP), local...
-
Software Validation and Verification Engineer
3 semanas atrás
Lisbon, Portugal Bosch Tempo inteiroJob Description Collaborate with development teams to understand software requirements and design effective validation and verification strategies. Implement and execute test plans, including unit tests, integration tests, and system tests, ensuring comprehensive coverage of software functionalities. Utilize C/C++ and Python programming skills to...
-
Internship - Validation Engineer
Há 2 dias
Lisbon, Portugal Renesas Electronics Tempo inteiroJob DescriptionCollaborator should be able to evaluate full PMICs through bench silicon validation techniques, including the hardware and software setup preparation. As part of silicon validation and delivery of results, the collaborator shall prepare evaluation plans for each specific product and provide documents to report results within planned and agreed...
-
Test Engineer
4 semanas atrás
Lisbon, Portugal ValGenesis Tempo inteiroValGenesis is looking for QA/Test Engineers to join and strengthen our development team based in Lisbon, Portugal. Test engineers will be part of the development scrum teams, and will closely work with the developers, BA/PO to ensure that all digital products are properly verified before reaching the clients. Responsibilities Develop deep expertise in our...
-
Test Engineer
4 semanas atrás
Lisbon, Portugal ValGenesis Tempo inteiroValGenesis is looking for QA/Test Engineers to join and strengthen our development team based in Lisbon, Portugal. Test engineers will be part of the development scrum teams, and will closely work with the developers, BA/PO to ensure that all digital products are properly verified before reaching the clients. Responsibilities Develop deep expertise in our...
-
Senior Data Analyst
Há 1 mês
Lisbon, Portugal Veeva Systems Tempo inteiroThe Role Veeva Link envisions building connected data applications to improve research and patient outcomes. Link Medical Insight is a product that captures, reveals, and disseminates medical insights across the enterprise, enabling medical teams to refine strategy based on scientific insights.As one of our Senior Data Analysts, you will be the subject...
-
Senior Medical Analyst
4 semanas atrás
Lisbon, Portugal Veeva Systems Tempo inteiroThe Role Veeva Link envisions building connected data applications to improve research and patient outcomes. Link Medical Insight is a product that captures, reveals, and disseminates medical insights across the enterprise, enabling medical teams to refine strategy based on scientific insights.As one of our Senior Data Analysts, you will be the subject...
-
Evidence Generation Specialist
Há 1 mês
Lisbon, Portugal AstraZeneca Tempo inteiroEvidence Generation Specialist - Study Delivery and Quality Management Location: Lisbon, Portugal (hybrid) Introduction to role: Join us at AstraZeneca as an Evidence Generation Specialist - Process and Study Delivery. In this role, you are responsible for the study implementation of AZ sponsored studies, oversight of Externally Sponsored Studies...
-
Evidence Generation Specialist
4 semanas atrás
Lisbon, Portugal AstraZeneca Tempo inteiroEvidence Generation Specialist - Study Delivery and Quality Management Location: Lisbon, Portugal (hybrid) Introduction to role: Join us at AstraZeneca as an Evidence Generation Specialist - Process and Study Delivery. In this role, you are responsible for the study implementation of AZ sponsored studies, oversight of Externally Sponsored Studies...
-
Procurement Specialist- Pharma
2 meses atrás
Lisbon, Portugal Hovione Tempo inteiroJoin a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...
-
Procurement Specialist- Pharma
4 semanas atrás
Lisbon, Portugal Hovione Tempo inteiroJoin a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...
-
Oracle DBA Migration Specialist
3 semanas atrás
Lisbon, Portugal Link Consulting Tempo inteiroAt Link Consulting (Permanent / Contractor), in Lisbon, PortugalExpires at: 2025-01-16Remote policy: Full remoteWe are seeking a highly skilled Oracle DBA Migration Specialist . The ideal candidate will have extensive experience in Oracle database administration and a strong background in database migration projects. The Oracle DBA Migration Specialist will...
-
Supplier Quality Assurance Specialist
2 meses atrás
Lisbon, Portugal Hovione Tempo inteiroJoin a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...
-
Supplier Quality Assurance Specialist
4 semanas atrás
Lisbon, Portugal Hovione Tempo inteiroJoin a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping...
-
Marketing Operations Specialist
Há 1 mês
Lisbon, Portugal ValGenesis Tempo inteiroValGenesis is seeking an experienced Marketing Operations Manager to join our team. As the Marketing Operations Manager, you will play a pivotal role in aligning our marketing strategies with our business objectives. You will oversee the planning, execution, and measurement of marketing campaigns, ensuring they are effectively driving lead generation,...
-
Marketing Operations Specialist
4 semanas atrás
Lisbon, Portugal ValGenesis Tempo inteiroValGenesis is seeking an experienced Marketing Operations Manager to join our team. As the Marketing Operations Manager, you will play a pivotal role in aligning our marketing strategies with our business objectives. You will oversee the planning, execution, and measurement of marketing campaigns, ensuring they are effectively driving lead generation,...
-
Sr Quality Assurance Specialist- FSP Team
3 semanas atrás
Lisbon, Portugal LIS Fortrea Development Ltd Sucursal em Portugal Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...