SteriMax is a proudly Canadian company serving the Canadian healthcare system, with strategic direction and decision-making anchored in Canada. To support our growing global operations, we have expanded select roles to our India office, positioning our team closer to key manufacturing and operational partners across Asia. This enables more effective collaboration and stronger execution – while maintaining the high standards and quality SteriMax is known for.
Description
Under the direction of the Senior Manager, Quality Compliance, the Specialist, Supplier Quality supports the GMP compliance of manufacturers, contract laboratories API Manufacturers, Packaging Material and GMP service providers and is responsible for, but not limited to, on site and virtual auditing, documentation review and all aspects of Supplier Quality Assurance. In addition, the candidate is skilled in preparing detailed audit schedules, audit reports,
and CAPA follow-up activities to ensure continuous compliance and quality improvement. This key candidate applies his/her previous pharmaceutical auditing experience and produces comprehensive audit schedules, reports and recommendations.
Typically, qualified people have held various Quality Assurance roles and have a strong knowledge of cGMP. Strong analytical, organizational, and communication skills enable the candidate to effectively collaborate with cross-functional teams and external suppliers while maintaining a high standard of quality oversight.
Key Responsibilities
- Qualification of the recent and existing suppliers and service providers
- Manages audit schedule and completes scheduledaudits on time.
- Drives delivery of day-to-day SupplierQuality, ensuring adherenceto audit plan and schedule.
- Providesadvice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.
- Primary contact for com