Pharmaceutical Quality Assurance Senior Associate
This exciting new role is a key position in ensuring the company's products align with regulatory mandates, uphold quality benchmarks, and comply with established validation procedures.
The successful candidate will have a comprehensive grasp of TGA/GMP principles, quality systems, and leadership in overseeing a quality function.
1. Validation and Compliance Oversight:
* Develop and maintain the validation master plan for GMP operations, 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.
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 Corrective Actions.
3. Team Development:
* Mentor and offer guidance to a team of quality professionals, facilitating their continuous growth and performance.
* Cultivate a collaborative working atmosphere within the quality assurance team.
* Ensure efficient communication and collaboration with other departments.
Requirements:
This challenging role requires a bachelor's degree in a scientific or engineering field and minimum 3 years of experience in quality assurance, validation, and compliance in a GMP environment.
The ideal candidate will possess strong knowledge of GMP regulations, quality management systems, and validation principles.
What We Offer:
* A supportive and collaborative work environment that values teamwork, innovation, and excellence.
* Opportunities for professional growth and development in a dynamic organization.