- Handle and monitor the implementation of validation protocols, guaranteeing accomplishment and documentation of validation actions in a timely manner
- Focusing on Qualified Infrastructure in collaboration with our Enterprise Architecture department and other pertinent stakeholders
- Stay updated on industry regulations, guidelines and best practices linked to CSV and incorporate them into the business's procedure
- Perform risk assessments as well as offer leadership on risk mitigation methods linked to computerised systems
- Write validation plans, IQ, OQ, PQ protocols and validation reports for multiple computerised systems
- Evaluate and sign off on user requirement specifications, functional specifications and risk assessment connected to computerised systems
- Work alongside cross-functional teams to outline validation needs for new equipment, systems and system upgrades
- Other duties may be assigned
- Is educated to a degree level in a computer science, engineering, life science or similar discipline, though an advanced degree would be ideal
- 4 years of experience in Computer System Validation, preferably within the logistics or healthcare industry
- Can Demonstrate experience within computerised systems validation in a regulated organisation such as pharmaceuticals, biotechnology, medical devices, etc.
- Shows expertise in regulatory needs such as FDA, EMA, etc., as well as industry standards such as GAMP 5, 21 CFR Part 11, etc. connected to CSV
- Shows leadership and project management abilities with the capacity to efficiently guide a team and handle various projects concurrently
- Have excellent communication skills, both verbal and written
- Is able to work effectively with others in cross-functional teams and regulatory agencies
- Can familiarise with validation documentation, risk assessments, and validation implementation
- Is fluent in the English language
- Permanent contract (with basic salary in 14 installments per year)*
- Private medical care
- English courses - financial or co-financed by company
- Food allowance (EUR 8.32, per working day)
- Work schedule 35h/week
- Hybrid and flexible work (3 days in a week at the office)
- Comprehensive onboarding program
- Buddy assistance
- Good access to public transports
Senior CSV Manager - Lisbon, Portugal - DSV
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DSV is on the lookout for a Computerised System Validation (CSV) Senior Manager to be a vital part of our IT Healthcare Center of Excellence team. If you thrive on navigating the dynamic landscape of CSV and are passionate about ensuring compliance with industry standards, then this is the opportunity you have been waiting for As a CSV Senior Manager, you will be at the forefront of implementing validation processes, keeping pace with industry regulations, and leading risk mitigation strategies. Your expertise will shape the future of DSV's healthcare technology, and your contributions will resonate globally.
This is a permanent position within our Global IT organisation, with potential openings available in Denmark, Poland, Portugal, and India. If you are looking for a role where you can apply your skills and knowledge in a dynamic environment, we encourage you to apply.
As a CSV Senior Manager, You will:
The Ideal Candidate:
What we offer:
DSV – Global Transport and Logistics