Quality & Validation Systems Specialist (Pharma)
Hovione
- Lisboa
- Permanente
- Horário completo
- 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)
- 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.