QA and Compliance Senior Associate - Pharmaceuticals

Job Description

QA and Compliance Senior Associate - Pharmaceuticals 2 days ago Be among the first 25 applicants Our client specializes in manufacturing medical pharmaceutical products, committed to delivering safe, high quality and effective medicines to Physicians and their patients. Their cutting-edge facility operates under rigorous Good Manufacturing Practices (GMP) protocols to guarantee the safety, purity, and uniformity of medicines. The Role: The successful candidate will be instrumental in ensuring the company products align with regulatory mandates, uphold the utmost quality benchmarks, and comply with established validation and adherence procedures. This role requires a comprehensive grasp of TGA/GMP principles, quality systems, and leadership in overseeing a quality function. Key Responsibilities: 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. 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). 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. Qualifications: Bachelor's degree in a relevant scientific or engineering field; advanced degree is a plus. Minimum of 3 years of experience in quality assurance, validation, and compliance in a GMP environment. Pharmaceutical industry experience is essential. Strong knowledge of GMP regulations, quality management systems, and validation principles. Benefits: Competitive salary commensurate with experience. Opportunity for professional growth and development in a dynamic and growing organization. A supportive and collaborative work environment that values teamwork, innovation, and excellence. To apply to this exciting new role, please forward your CV to or alternatively contact Patricia Espina on 0489 923 504 or Lucia Kimonides on 0410 565 626 for a confidential discussion. Kindly note that only shortlisted candidates will be contacted - thank you! Seniority Level Mid-Senior level Employment Type Full-time Job Function Quality Assurance Industries Pharmaceutical Manufacturing, Hospitals and Health Care, and Agricultural Chemical Manufacturing #J-18808-Ljbffr