Senior Pharmaceutical Compliance Specialist
2 weeks ago
The Quality Associate plays a crucial role in ensuring the quality and safety of compounded products.
Working closely with Operations, this team member will maintain GMP-compliant practices.
This is an exciting opportunity to drive innovation and make a meaningful impact in patient care.
Key Responsibilities- Investigate incidents, deviations, and complaints in a timely manner.
- Conduct root cause analyses and prepare responses to customer complaints.
- Participate in risk assessments, change control, validation, internal audits, document reviews, and CAPA activities.
- Train staff on quality procedures and requirements, ensuring complete training records.
- Provide guidance on quality processes and procedures as needed.
- Maintain and organize the site micro laboratory.
- Coordinate cytotoxic/antibiotic residue monitoring of cleanrooms.
- Support Environmental Monitoring activities and perform quality assessments of quarantined incoming goods.
- Experience in GMP-compliant pharmaceutical manufacturing environments.
- Background in sterile compounding (desirable).
- Development and application of Quality Systems.
- Regulatory experience (e.g., TGA).
- Continuous quality improvement expertise.
- Proficiency in common IT software.
- Strong project, time, and task management skills.
- Tertiary qualification in a Science discipline (preferably microbiology or chemistry).
A successful candidate will excel in a fast-paced environment, demonstrating strong communication and leadership abilities.
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