Australia Job Openings
Pharmeng Technology Inc
Quality Assurance Specialist
Melbourne
FULL TIME & CONTRACT
October 7, 2024
Job Title: Quality Assurance Specialist
Location: Melbourne, Australia
Employment Type: Full-Time/Contract
Key Responsibilities:
- Ensure compliance with local and international pharmaceutical regulatory requirements (e.g., TGA, FDA, EMA).
- Conduct internal audits and support external audits by regulatory agencies.
- Monitor and maintain the company's Quality Management System (QMS).
- Review and approve batch records, ensuring adherence to Good Manufacturing Practices (GMP).
- Handle deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Assist in the development and implementation of quality policies and standard operating procedures (SOPs).
- Work collaboratively with cross-functional teams, including production, R&D, and supply chain, to ensure product quality.
- Conduct training sessions on quality assurance and GMP compliance for staff.
- Bachelor’s degree in pharmaceutical sciences, biotechnology, or related field.
- Minimum of 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP and regulatory requirements (TGA, FDA, EMA).
- Experience with QMS and CAPA management.
- Excellent attention to detail and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
- Proficiency in Microsoft Office and quality management software.
- Opportunity to work with a leading pharmaceutical company in Australia.
- Competitive salary and benefits package.
- Career growth and development opportunities.
- Supportive and inclusive work culture.
Join Us: If you are a dedicated and highly motivated QA specialist with a passion for ensuring the highest quality and compliance standards, we encourage you to apply. Pharm Eng offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Become a part of our team and contribute to the success of our industry-leading solutions.
Pharm Eng is an equal opportunity employer and welcomes candidates of all backgrounds to apply.
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