Manager, Quality Assurance-ARPL-QA&C AR

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.