QUALITY ENGINEER ensures the validation of the sterilization processes are executed to relevant standards and the Quality Management System is adhered to ensuring compliance to relevant standards and regulations
DUTIES AND RESPONSIBILITIES:
- Responsible for review of customer processing validation protocols and reports to ensure compliance with relevant standards and specific procedures.
- Initiation of corrective action, verifying the effectiveness of corrective actions and generation of quality reports. Adherence to closure due dates to ensure objectives are achieved.
- To initiate, investigate, control, and analyse non-conformance reports ensuring all relevant parties are informed. Adherence to closure due dates to ensure objectives are achieved.
- To initiate, investigate, control, and analyse the recording and investigating of customer complaints. Adherence to closure due dates to ensure objectives are achieved.
- Managing and identifying training requirements and attending necessary training sessions/courses to ensure training requirements are completed and up to date.
- Providing training within area of expertise as required and supporting all department and site training activities
- To be responsible conducting internal and inspectingexternal calibration of all calibrated instrumentation. Performing all relevant checks on a regular basis.
- Provides required preparation and auditing support re QMS and validations during internal and external audits conducted by Customers, notified bodies and Regulatory Agencies.
- Ensure Internal audit schedule is performed as agreed within timescale. All actions resulted from Internal Audits are being addressed.
- Review of routine batch records to ensure customer product is processed as per customer agreed specifications. To be responsible for product release for all processing at the site.
- Implements change as per validation and change control processes.
- To undertake projects as and when required including quality support for other sites
Experience working in quality role as well as in a regulated environment (e.g., ISO 13485, ISO 9001 etc). A degree in Life Science and quality experience are desirable but not essential.