
Ensurer of Pharmaceutical Excellence
7 days ago
We are seeking a Quality Associate to ensure quality and safety in our compounded products.
Key Responsibilities:- Investigate incidents, deviations, and complaints in a timely manner.
- Conduct root cause analyses of non-conformances and supplier/customer complaints.
- Prepare customer complaint responses and monthly reports.
- Participate in risk assessments, change control, validation, internal audits, document reviews, CAPA, and recall activities.
- Train staff on quality procedures and requirements.
- Provide guidance on quality processes and procedures as requested.
- 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.
- Drive continuous improvement in Quality performance and promote a quality culture.
- Experience in GMP-compliant pharmaceutical manufacturing environments is essential.
- Knowledge of sterile compounding environments would be beneficial.
- Application of Quality Systems experience is required.
- Regulators of pharmaceutical manufacture experience is necessary.
- Continuous quality improvement experience is crucial.
- Competency in common IT software is necessary.
- Strong project, time, and task management skills are required.
- Tertiary qualification in a Science discipline such as microbiology or chemistry is preferred.
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