Marketing Company Operations Quality Associate Director Astrazeneca Pharma India Ltd.

Typical Accountabilities

• Maintain and update local Quality Management System (QMS) in alignment with AstraZeneca PQS and local regulations, to cover GMP/GDP activities related to AAPI scope.
• Ensure effectiveness of the QMS across GMP/GDP areas in accordance with AstraZeneca Standards and local regulations.
• Ensure that all functional QMS elements are in place, as described the MCOQ Quality Manual.
• Monitor and report key quality metrics to senior management to assure the effective deployment of the quality system.
• Responsible for coordination of Quality Management reviews across GxP functions in the JV.
• Align with AstraZeneca Strategy for local execution in term of AAPI Quality system.
• Management of local suppliers quality management with direct participation, covering the whole supplier lifecycle.
• Perform local suppliers audits and report supplier s quality risk assessment.
• Participate in the ESM meetings (Operational review / S&OP meeting, Supplier Performance Review meeting) and Mkt Access External Ops Team Review.
• Assure appropriate records management and record retention practices are being employed within the CMOs sites.
• Interface directly and work closely with External Quality Team and local regulatory team in relation with CMOs/Manufacturing sites to:
  • Ensure active participation on global Quality initiatives from a strategic GMP compliance perspective.
  • Ensure product quality and patient safety prior batch release to market.
• Collaborate closely with CMOs representatives to ensure reliable supply of relevant commercial products.
• Identify trends and communicate identified risks and related mitigation actions.
• Ensure Continuous Improvement by:
  • Strive to continuously improve the established ways of working.
  • Monitor KPIs related to QMS and propose remedial & Improvement actions through continuous improvement plan.
• Perform periodic self-inspections.
• Handle and manage local change controls and impact assessment of global change controls.
• Supports local AAPI MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation of effective self-assessment programs.
• Manage GQA audits and local inspections.
• Manage product quality complaints (PQC) and recalls.
• Provide training, supporting and coaching structure for Quality roles.
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site/MC leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams.
• Supports AAPI JV to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation of effective self-assessment programs.
• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• Contributes to development local procedures due to specific local regulatory requirements, and provides some technical input into the development of global procedures and standards.
• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring appropriate level of compliance