Technical Operations Specialist - QMS
R&D Partners View all jobs
- Tipperary
- Permanent
- Full-time
- Prepare and update documents such as change controls, deviations, investigations, risk assessments, protocols, and training materials.
- Use key software tools like SAP, E-log, E-BR, Leucine, and Trackwise for documentation and tracking.
- Review manufacturing records in real-time to ensure accuracy and eliminate errors.
- Conduct post-batch reviews of manufacturing and packaging records within set timelines.
- Work flexible shifts (12-hour or 8-hour) based on business needs to maintain compliance on the shop floor.
- Review and ensure documentation aligns with process validation, facility, utility, and equipment qualification requirements.
- Provide technical support to operations teams to improve efficiency and achieve goals.
- Develop and implement projects to enhance manufacturing and supply chain processes.
- Collaborate with other departments to address manufacturing needs and implement solutions.
- Ensure compliance with the Pharmaceutical Quality System and identify opportunities for improvement.
- Foster seamless collaboration between operations teams and other business units.
- Perform additional tasks as assigned by the department head.
- Strong organizational skills with attention to detail for preparing and reviewing documentation.
- Familiarity with manufacturing software tools such as SAP, E-log, and Trackwise.
- Ability to work flexible shifts to meet business demands.
- Knowledge of pharmaceutical quality systems and compliance standards.
- Problem-solving mindset with a focus on improving processes and efficiency.
- Effective communication and teamwork skills to collaborate across departments.
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