Computer Validation Specialist

3 semanas atrás

Lisboa, Portugal Adamas Consulting Tempo inteiro

Company Description

**Job Description**:
To provide high quality, professional quality assurance and quality management services to the pharmaceutical industry. Duties will be carried out in accordance with the ADAMAS Quality Management System (QMS) including business and personal objectives as agreed during the annual performance appraisal process.
- Assist in Development, implementation, and maintenance of computerized system’s state of validation and compliance throughout its SDLC.
- Assist, Author/Review in Preparation of CSV deliverables such as Validation Plan, Test Plan, Summary Reports
- Assist in supporting CSV vendor and system process audits
- Assist in supporting CSV and QMS internal audits
- Assist in authorship, generation, and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP regulated computerized systems
- Review test scripts including IQ, System Testing and UAT scripts.
- Perform Data Integrity, Supplier Qualification and FDA 21Part 11 assessments.
- Assist in support computerized systems change management control and periodic review processes.
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to accomplish results
- Performing other duties as assigned

**Qualifications**:

- Attention to detail
- Accountability in the workplace
- A minimum of a bachelor’s degree in Science, Engineering or equivalent technical discipline is required
- Preferred to have knowledge of validation of GxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations
- Preferred to have Typing speed of 80+ wpm
- Effective written and oral communication skills
- Excellent time management, interpersonal and problem-solving skills.
- Must demonstrate the ability to excel in a collaborative team-working environment.
- Ability to Author SOPs and Work Instructions (WI) would be an advantage

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.

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