Quality Assurance Specialist

5 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 4,50,000 - ₹ 5,50,000
Job Description
  • The primary responsibility of this role is to ensure compliance with GxP and quality standards, which includes managing day-to-day process activities under complaint hub responsibility.
  • This involves identification, reporting, and escalation of critical complaint events, along with building strong collaboration with stakeholders to guarantee customer service, compliance, and efficiency.
  • The professional will perform reconciliations with relevant parties, such as NPS and MedInfo, and respond to clients regarding the final outcome of complaints.
  • Preparation and evaluation of Quality trends are also key responsibilities, as well as supporting teams in driving Continuous improvement for processes and product quality performance.

Key Responsibilities:

  • Ensure that local Quality System and Standard Operating Procedures are in place for all GxP-related activities and maintain compliance with cGMP through training and internal audits.
  • Timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting.
  • Support and track the implementation and maintenance of the local Quality system according to the Novartis Quality Manual.
  • Manage processes and systems for all GxP Quality Assurance, including Change control, Training Management, Escalation Management, and Risk Management.

Required Skills and Qualifications:

  • Quality standards are understood, designed into work activity, and achieved.
  • In accordance with departmental objectives, support projects with agreed quality and delivery date, and pass internal and external inspections.

Benefits:

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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