- Reference: GY46417
- Job Type: Permanent
- Location: Mayo
- Category: Science, Pharmaceutical & Food
- Excellent opportunity for individual development across systems, equipment and production processes with an industry leading, highly automated, fast moving Pharmaceutical team.
- With the current team, support the business unit data Integrity enhancements for process automation systems.
- Complete data Integrity reviews and subsequent remediation activities of business units systems and processes.
- Generate data process maps to describe the data flows throughout the systems and to identify critical data control points/transactions.
- Identify data integrity gaps and propose solutions.
- Lead and/or assist with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps.
- Lead and/or assist the development of critical alarm matrix for systems which will be lead into procedural controls.
- Develop training modules to continue the upskill and awareness of data integrity across the business unit.
- Develop matrix of the systems access levels across users, set ups, administrators and engineers.
- Oversee the data integrity compliance of new installs and upgrades to meet Annex 11 and 21CFR Part 11
- Updating of the current system risk assessments and risk mitigation plans. Completion of risk assessments for new installs.
- Support system administrators in the effective audit trial reviews.
Skills, Experience and Qualifications required for this position:
- Third level qualification in Engineering / Science.
- Experience: +3 years working in a regulated environment.
- Solution focused, with in-depth technical knowledge of both procedural controls and system controls for managing data Integrity.
- Must be motivated and passionate about production systems.
- Excellent documentation, organisational and prioritisation skills.
- Ability to organize work load and work on own initiative.
- Ability to effectively communicate plans, proposals, and actions at management levels.
- Demonstrated problem solving skills.
- Experience in a highly automated manufacturing desirable
- Qualification in computer science/automation/mechatronic engineering.
- Knowledge of the GAMP guidelines applicable to computer system validation.
- Experience supporting Siemens, Allen Bradley, PLC, SCADA and HMI systems in a manufacturing environment.
- Knowledge of regulatory requirements in a pharmaceutical GxP environment.
- A strong understanding of current data integrity expectations would be a distinct advantage.
- Strong knowledge of Annex 11 and 21CFR Part 11
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org
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