Computerised System Validation Expert
3 settimane fa
We are seeking a highly skilled Computerised System Validation Specialist to join our team at Maasi Enterprises Ltd. As a key member of our Life Sciences sector, you will be responsible for ensuring the validation of computerised systems in the pharmaceutical industry.
Key Responsibilities:- Independently manage the design and execution of tests for computerised systems.
- Provide client support in software system validation.
- Develop validation plans, conduct tests, collect and evaluate results, and prepare validation reports.
- Define and write validation plans, validation reports, test plans, acceptance tests, user requirements, and manage change control and periodic review processes.
- Conduct data integrity assessments and write and review standard operating procedures and work instructions.
- Draft design and functional specification documents in cooperation with system or process engineers and manage formal revision and approval processes.
- Write and execute IQ/OQ/PQ test protocols for computer systems, processes, equipment, and utilities.
- Perform technical impact assessments and write and review calibration and maintenance plans.
- Develop IT/OT infrastructure qualification plans, tests, and procedures.
- Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.).
- Language skills: Italian and English CEFR C1 level or higher (read, written, and spoken).
- Utmost professionalism and seriousness towards customers and colleagues.
- Internal and external training programs.
- Performance bonuses.
- Overtime pay in compliance with regulations.
- Team building activities.
Maasi Enterprises Ltd is an inclusive and equitable company that values differences and welcomes people from all walks of life. We believe in equal opportunities for everyone and apply fair working conditions and salaries related to assigned responsibilities, skills, and personal merit.
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