Quality Assurance Manager
We are seeking a Quality Assurance Manager to join our team. The successful candidate will be instrumental in ensuring our products align with regulatory mandates, uphold the utmost quality benchmarks, and comply with established validation and adherence procedures.
Key Responsibilities:
1. Validation and Compliance Oversight:
* Develop and maintain the validation master plan for the GMP facility, encompassing equipment, processes, and systems.
* Ensure compliance with all relevant regulatory standards, including TGA and ODC, as well as other applicable agencies.
* Supervise the development and execution of validation protocols and reports, such as IQ, OQ, and PQ.
2. Quality Assurance System Management:
* Establish and sustain a comprehensive quality assurance system covering all facets of GMP operations.
* Conduct routine internal and external audits to verify compliance with quality standards and regulatory mandates.
* Identify and rectify quality issues through root cause analysis, deviations, and CAPA (Corrective and Preventive Actions).
3. Team and Development:
* Mentor and offer guidance to a team of quality professionals, facilitating their continuous growth and performance.
* Cultivate a collaborative and proactive working atmosphere within the quality assurance team.
* Ensure efficient communication and collaboration with other departments, such as production, engineering, and regulatory affairs.
* Deliver weekly reports to executives and determine duties and priorities accordingly.
Bachelor's degree in a relevant scientific or engineering field; advanced degree is a plus.