- Implementation of policies and procedures to validate/qualify computer systems.
- Plan, coordinates and participate in a compliant validation process for quality information technology systems which requires formal validation documentation (FAT, SAT, IQ, OQ and PQ) under appropriate regulatory requirements and company manufacturing standards.
- Generation of project Validation Master Plans.
- Review and approval of third party generated protocols and reports
- Participate in data integrity risk assessments and / or Design FMEAs.
- Analyze the results of testing and determines the acceptability of results against predetermined criteria.
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
- Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Lead process improvement projects to improve the validation of computerized systems.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Participate in regulatory audits and communicates company’s computer validation policies.
- Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
- Prepare data/presentations and attend review meetings.
- Compliance to all local site Environmental, Health and Safety regulations
- Compliance to all local site company policies, procedures and corporate policies.
- Perform additional duties at the request of the direct supervisor.
Science or engineering degree with a first experience
Experience in the development, support &, improvement of production systems in a manufacturing environment.
Excellent communication / interpersonal skills.
Enthusiastic and energetic with the ability to integrate quickly into a team environment.
Demonstrated flexible and innovative approach to work.
Strong knowledge in data integrity
Familiar with SDLC based on GAMP 5 A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 11/ Annex 11 is essential.