Manager, Quality Assurance-ARPL-QA&C AR

About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary
To implement efficient, quality processes at ARPL in alignment with global standards that comply with heath authority requirements. Responsible for monitoring of activities related to

• Product Market Complaint System
• Internal and Vendor audit management
• Supplier Management
• Quality Agreements
• Artwork Management
• Nitrosamine assessment and management.
• People Management

Job Responsibilities

• Responsible for handling Health Authority Inspection.
• Ensure adherence to GMP regulatory requirements by one and all in the facility.
• Responsible and accountable for competently managing subordinates and to provide all required training, equipment, tools and follow procedures in accordance with applicable regulatory & other pertinent requirements.
• Prioritize the closure of Complaints within the stipulated timeline.
• Review and approval of Market Complaints Investigation and complaint trend report.
• Responsible for application of Quality Systems and enhancement of the Establish metrics to measure the effectiveness of the system.
• Manages the Product Market Complaint System, CAPA & Filed Alert Reports (FAR's) to ensure timely completion of site investigations and responses to submitted complaints.
• Manages the Quality System Metrics, Trending and Monitoring.
• Co-ordination with Site stake holders for escalation of site incidents like critical incidents, and market complaints to global field market response team Apotex Inc., Canada.
• Coordinate and manage internal and supplier/vendor audit program.
• Preparation and coordinating for internal/ external audits and ensuring compliance to Regulatory guidelines.
• Review and approval of Water Trend Reports.
• Coordinate and manage Cross Contamination Control Program.
• Change control assessment/approval related to Quality system procedures, Artwork, Material codes, Supplier drivern changes etc.
• Review and approval of commercial printed packaging material Artworks.
• Managing supplier qualification program including scheduling of audits for raw material manufacturer, packaging materal manufacturer and service providers.
• Review and approval of reduced testing program.
• Review of quality agreement related to raw material manufacturer, packaging materal manufacturer and service providers.
• Review of quality agreement related to Apotex Affiliate and customers for finished product.
• Responsible for implementation of project related to Artwork management and supplier management.
• Certified trainer for GMP Modules at ARPL.
• Review Nitrosamine risk assessmet report.
• Coordinate and manage Nitrosamine Control Program
• Assists the Seniors & Senior Manager, Quality Assurance in achieving departmental goals and objectives.
• Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/ trends.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

Job Requirements

• Education

• Minimum Bachelor of Pharmacy/ Science or any equivalent degree.

• Knowledge, Skills and Abilities

• Experience in handling of Investigation.

• Experience in Audit management.
• Experience in In-process Quality Assurance and Quality Mangement System.
• Hands-on experience in Electronic Document Management Application ( Example:Trackwise application, SAP etc.,)
• Process technical skills in investigation tools and techniques.
• Strives to drive projects related to Quality Management Systems.
• Having Problem-solving, Decision-making, Planning, Delegation, Communication and Time management skills.
• Should possess leadership skills to lead teams.

• Should be a strong team player.

• Experience

• Minimum 13 years of experience in GMP Regulated pharmaceutical industry.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.