Specialist, Quality Compliance US-GQC-CA&SQ C

Job Summary

Reporting to the Quality Compliance Manager, the Specialist, Quality Compliance - US at the Apotex Indianapolis Distribution Center is responsible for developing and analysing quality metrics data and generating quality reports. This role independently provides technical leadership and expertise with respect to the deviations and CAPA process.

This role also supports Quality Compliance Manager to ensure site deviation investigations are handled and completed in a timely, compliant and efficient manner including compliance activities such as escalation, quality risk review board and, site management review. Also, supporting Quality Compliance Manager in providing the oversight of cGMP and Drug Enforcement Administration (DEA) related activities at the site, internal audit program and, maintaining the site audit readiness.

Job Responsibilities

• Responsible for enforcing DEA related controlled substances laws and regulations at the site
• Provide direct Quality oversight/support to address deviation investigations including impact assessment and disposition. Approve proposed CAPA actions.
• Supports the Quality Compliance Manager in overseeing the satisfactory resolution of Quality and controlled substances related issues impacting cGMP compliance and DEA laws & regulations.
• Responsible for providing Compliance oversight for executional activities pertinent to controlled substances and associated documentation.
• Develop, compile and analyze daily, weekly, monthly and quarterly QPIs Metrics for the Indianapolis-US site, including but not limited to Deviation/CAPA/Change Controls/ Complaints and other Metrics Report for management.
• Perform trending and reporting of Quality Performance Indicators to monitor the overall health of the Pharmaceutical Quality System. Lead change to response to issues and concerns identified, consistent with quality programs and regulatory requirements.
• Perform trending and reporting of Deviations to monitor effectiveness of investigations and CAPAs. Analyze cause and defect items and liaison with responsible departments to resolve issues and reduce overall risk.
• Manage the Deviation and CAPA system, including facilitation of the Weekly Deviation Review meetings. Review on-going progress on all open Deviations/ CAPAs. Notify appropriate individuals and area management on status and escalate issues related to overdue tasks for areas.
• Act as Super User and Certified trainer for the Trackwise system. Train all new staff on Trackwise system and GMP modules as required.
• Work closely with Global team to develop new programs and systems that improve the overall functionality of the Deviation system including validation activities.
• Support management in preparation of Escalation/Site Management/Quality Risk Review Board meetings. Preparation meeting Agendas and Minutes ensuring decisions are appropriately documented and action items are addressed/followed-up. Act as designate and facilitate meeting including decision making in the absence of Manager.
• Maintain and track status of risk registry for the site. Liaison with responsible departments to perform risk assessment and develop risk control strategy.
• Provide necessary support before, during and after Regulatory and Customer inspections including logistics, participation in inspection team, provision of requested document, trend reports, coordination of audit responses etc.
• Effectively communicate at all levels within the organization (including Apotex affiliates) and with external customers.
• Recommend and participate in the implementation of process improvement initiatives to maximize efficiency and improve compliance.
• Troubleshoot departmental problems and make recommendations for solutions in consultation with other relevant staff.
• Ensure that all work is performed in full compliance with GMP, GDP, SOD, and established safety standards.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Education: Bachelors degree in science
    
    
• Knowledge, Skills and Abilities
  • In-depth knowledge in cGMP and DEA regulations and standards as applicable to the pharmaceutical industry
  • Working knowledge in Good Distribution Practices and application of Good Logistic Management principles would be an asset
  • Working knowledge with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP)
  • Clear and concise written and verbal communication in Apotex’ s language of business
  • Demonstrated organizational skills, attention to details, and excellent problem solving skills including analytical and critical thinking
  • Demonstrated ability to effectively manage multiple priorities in a fast-paced environment
  • Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential information
  • Work independently or in a team setting to achieve individual, departmental and organizational goals
  • Competent with computer systems and various software platforms
  • Minimum 5 years experience in pharmaceutical industry, preferably in a Quality Assurance
  • Experience in project management and quality risk management
    
    
• Experience
  • Minimum two to five years of relevant experience in pharmaceutical industry, preferably in a Quality Assurance
  • Experience in Pharmaceutical Manufacturing operations and controls, change management processes, DEA regulations would be an asset
  • Working knowledge and/ or hands-on experience with the Pharmaceutical Quality Systems would be an asset