Senior Pharmaceutical Quality Compliance Specialist
2 days ago
About Slade Health
Slade Health is a leading national sterile compounding service provider with TGA accredited manufacturing facilities across Australia and New Zealand. With over 50 years of experience, we have established ourselves as a well-respected industry name in the production of aseptically compounded pharmaceutical products.
The Role
We are seeking an experienced Senior Pharmaceutical Quality Compliance Specialist to join our Quality team. As an integral member, you will report to the Quality Pharmacist Supervisor and site Quality Manager, working closely with Operations to ensure that our compounding centre operates in compliance with regulatory and GMP requirements.
Responsibilities
- Release compounded batches in accordance with GMP guidelines
- Participate in investigations and root cause analysis of non-conformances, supplier and customer complaints
- Conduct risk assessments, change control, validation, internal audits, document reviews, CAPA, and recall activities
- Liaise with stakeholders to complete action items related to quality procedures
- Develop and conduct training on quality procedures and requirements
- Support Environmental Monitoring activities and perform quality assessments on quarantined incoming goods as required
Requirements
- Experience in a GMP compliant pharmaceutical manufacturing environment
- Experienced in a sterile compounding environment
- Desirable: experience with regulators of pharmaceutical manufacture (e.g. TGA)
- Strong background in continuous quality improvement
- Proficiency in common IT software (MS Word, MS Excel, MS Visio)
- Competent in time and task management
- Tertiary qualification in a Science discipline
What We Offer
This is a permanent full-time position offering a competitive salary of $80,000 - $110,000 per annum, depending on experience. You will work a minimum of 76 hours a fortnight, Monday to Friday (shift times may vary). We also offer opportunities for professional growth and development, as well as a collaborative and supportive work environment.
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