Senior Quality Assurance Operations Manager

1 week ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 1,04,000 - ₹ 13,08,780

Key Responsibilities:

  • Lead and manage Quality operations team to ensure compliance with cGMP and Quality Management.
  • Oversee Operational activities of pharmaceutical products at Contract Manufacturing Organizations (CMOs) to meet Sanofi Quality directives and relevant regulatory requirements.
  • Monitor and release drug products in accordance with registered specifications and local regulations.
  • Ensure validations, qualifications, testing, change management, stability studies, deviation and investigation at CMO sites.
  • Collaborate with QA managers to evaluate and implement Quality compliance at CMOs.

Quality Management System:

  • Implement QMS systems compliance as per Sanofi Global procedures.
  • Participate in evaluating and defining CAPA/action plans/investigations at CMO sites.
  • Assess and approve Quality trends through APQRs and drive Continuous improvement for processes and product quality performance.
  • Investigate Product technical complaints for products manufactured at external manufacturing sites.
  • Manage quality escalations initiated from any quality system.

Additional Responsibilities:

  • Identify, control, and escalate proactive risks at CMOs.
  • Regularly oversee hub activities to ensure compliance and adherence to KPIs.
  • Conduct CMO Quality reviews as per the SQR calendar and implement action plans in a timely manner.
  • Develop and implement Quality improvement plans for CMOs.
  • Ensure valid Quality agreements with CMOs/ suppliers and define cGMP roles and responsibilities.

Requirements:

  • Minimum 12 years of experience in Quality Assurance, with 2-4 years of team handling experience.
  • Effective communication skills with external partners (CMOs).
  • Ability to work independently and make difficult decisions.
  • Strong analytical skills, cross-functional collaboration, teamwork, and stakeholder management.
  • Handling of different pharmaceutical dosage forms.
  • Managerial courage.

Education:

  • Bachelor's/Master's degree in Lifesciences or related field.

Languages:

  • English, Hindi.

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