Main purpose of job:
The role is to implement and execute tasks relating to day to day Operational Quality aspects. The role entails taking responsibility for Quality matters around process and documentation. The role also acts as the key point of contact with customers in relation to quality issues.
- The Quality Operations Manager will manage the generation and review of all batch manufacturing records as part of production start-up and post batch review activities, ensuring agreed timelines are met.
- Work with Quality Systems Manager to optimize QA performance and drive continuous improvement.
- Actively cross train QA staff across all Irish sites so that surges in demand can be met.
- The Qaulity Operations Manager will drive the update, review and maintenance of all forms and records related to quality activities.
- Review and approve deviations and investigations arising from the process or related to the products packed and respond to customer queries related to product investigations.
- The Quality Operations Manager will maintain compliance with GMP and customer expectations as defined in Quality Agreements.
- Schedule and manage the activities of the quality operations team
- Sets performance objectives/goals for quality operations team and regularly evaluate employee’s performance.
- Monitor and track the performance of batch file completion and evaluate performance against agreed indicators.
- Ensure that ongoing inspection and review of all logbooks and off-line documentation is performed.
- Manage and perform GEMBA walks on a frequent basis to monitor the housekeeping practices in the area and to evaluate GMP compliance.
- Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
- The Quality Operations Manager will also lead customer audits as required
The next Quality Manager should have a Degree level qualified in a scientific discipline coupled with extensive experience in the Pharmaceutical Industry at a senior level. QP qualification would be highly desirable but not compulsory
Must have experience of hosting Regulatory Inspections, client audits and knowledgeable of current EU Regulations and upcoming changes
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