Description:
Writing validation protocols and reports. This will Include but is not limited to: Packaging, sterilization and equipment validations (Equipment qualification as applicable).
Document control of all documents used in implementing and maintaining the quality management system.
Perform Quality review of documentation (Procedures and related forms and records).
Facilitating the effective and appropriate close out of Nonconformances, by
a. Liaising with the appropriate departments to ensure actions and corrective actions are taken to address the root cause.
b. Ensuring the process has been documented and supporting evidence has been included.
Where applicable, facilitate the process risk management procedure and ensure appropriate preventative actions are taken and all activities are documented.
Facilitate Departmental internal audits
Assisting with the facilitation of all third-party audits as directed by the department manager
Assisting with the facilitation of supplier audits as directed by the department manager
Identify areas to improve the QMS and facilitate required action.
Offering Regulatory support to departments related to product development including, where needed, assisting in the writing or reviewing of technical documentation and clinical evaluations.
Provide and facilitate training to staff for quality related processes and procedures.
To support day-to-day activities associated with maintaining QMS compliance
Requirements:
Min 2 years experience
Tertiary education in natural sciences or engineering