
Compliance Quality Assurance Manager
6 days ago
Perrigo is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.
The Compliance Supervisor plays a crucial role in ensuring the company's batch review and release process, deviation investigation and resolution process, internal audit process and customer complaint system are managed effectively.
Key Responsibilities:
- Ensure product is manufactured, stored and distributed in accordance with regulatory requirements.
- Review deviations in accordance with procedures and ensure suitable assessment of impact on quality, safety and efficacy has been performed and documented.
- Determine appropriate finished product batch disposition in accordance with procedures and regulatory requirements.
- Coordinate, maintain and improve process deviation systems, quality event systems and customer complaint systems.
- Conduct investigations into process deviations, quality events as well as customer complaints and implement required corrective and preventative actions.
- Ensure internal audits are conducted in accordance with current procedure and coordinates and administers the internal audit programs.
- Review and approval of controlled documents including SOPs, batch documents, periodic product quality reviews and controlled forms.
Required Skills & Qualifications:
- Tertiary qualifications in Science, Pharmacy or Engineering
- Experience in the development, operation and assessment of relevant quality control, assurance and management systems.
- A minimum 5 - 7 years' experience in the pharmaceutical industry
- Demonstrate involvement in TGA inspection (Inspection standards: PIC/S Guide to Good Manufacturing Practice for Medicinal Products and ISO 13485)
- Specific understanding of the requirements of Release for supply of medicines
- Exceptional skills in organisation, planning and communication
This position requires a strong understanding of regulatory requirements and excellent organisational skills to manage multiple priorities. The ideal candidate will have previous supervision experience and be able to liaise effectively with production, logistics and customer service personnel.
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