SteriMax Inc.
Website:
sterimaxinc.com
Job details:
Job Title - Specialist, Supplier Quality
Reports to: Sr. Manager, Quality Compliance
ABOUT OUR GLOBAL TEAM
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 new 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 communication of supplier quality issues with the suppliers/service providers.
- Responsible for tracking and monitoring the supplier’s performance and communication of the results to the suppliers as well as internal stakeholders
- Complete quality agreements of new supplier as per the procedure.
- Conducting risk-based supplier evaluation and prioritization for audits and oversight
- Supporting initial qualification, requalification, and de-listing of suppliers based on quality risk
- Ensuring alignment of supplier quality systems with internal SOPs and regulatory expectations
- Proactively looks for opportunities to identify change,increase efficiency, influence decisions and deliver results while ensuring compliance.
- Provides oversightand works to assure that supplier quality issues are resolved prior to launch release of drug Product.
- Participating in cross-functional quality review meetings (QA, QC, Regulatory, Supply Chain)
- Escalating critical supplier quality issues in a timely manner to ensure product quality and patient safety
- Supporting change control assessments related to suppliers, materials, or processes
- Maintaining audit readiness and ensuring all supplier documentation is in inspection-ready state
- Contributing to continuous improvement initiatives within the Supplier Quality function
- Prepare risk assessment reports for any overdue routine qualification activities
- Maintains positive and collaborative internal and external customer relationships.
- Maintains strong communication network with peers.
- Additional responsibilities as assigned
Leadership Responsibilities
- Responsible for building positive relationships at all levels
- Collaborate with the Senior Manager, Compliance with improving processes and complete projects
- Collaborate with the internal and external stakeholders
Job Requirements:
- Minimum bachelor’s degree in science (Microbiology/Biochemistry/Chemistry or Life sciences)
- At least 10+ years of auditingexperience in the pharmaceutical industry;
- Minimum of 5 years’experience in the sterilemanufacturing environments.
- Able to travel nationally and internationally, on a routine basis
- Trained and/or experienced with quality systemsi.e Supplier quality, CAPA, ChangeControl, deviations, GxP Documentation
- Experience writingSOP’s that meet US FDA GMPs and Health Canada GMPs
- Applied knowledge and experience with regulatory and customer inspections
- Experience working in eQMS i.e. DOT Compliance/TrackWise etc.
- Strong computer skills i.e. MS Office
- Effectively communicates in English (oraland written)
- Well-developed organizational /planning skills
Click on Apply to know more.