Senior Quality Assurance Professional

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 15,00,000 - ₹ 28,00,000
Job Title: Quality Specialist

The primary objective of this role is to ensure the highest standards of quality are maintained across all operations.

Key Responsibilities:
  • Collect, monitor, and report Quality Key Performance Indicators (KPIs) in a timely manner to facilitate effective management decision-making.
  • Support and coordinate Health Authority inspections and internal audits by providing accurate information and documentation on demand.
  • Maintain and implement local Quality systems according to the Novartis Quality Manual, ensuring compliance with all applicable regulations.
  • Manage processes and systems for GxP Quality Assurance, including Change control, Training Management, Escalation Management, and Risk Management.

Accountabilities:

  • Ensure full compliance with GxP and Novartis Quality standards in all processes.
  • Contribute to process improvement initiatives and/or implement modified processes as needed.
  • Adequately track and complete corrective and preventive actions (CAPA), escalating issues related to CAPA closure when necessary.
  • Review quality deliverables to ensure compliance with health authority requirements and SOPs, including procedural documents, records, third-party work, contractors, clinical trial material, components, and gap assessments.
Performance Metrics:
  • Departmental objectives, such as supporting projects with agreed-upon quality and delivery dates, and passing internal and external inspections.
  • Maintaining sound working relationships with partners and customers.
  • Demonstrated leadership of specific GxP areas, early external/industry engagement, and basic financial knowledge (e.g., cost management, budget forecast).

Requirements:

  • Functional breadth and operational management experience.
  • Collaboration across boundaries.
  • Project management expertise.

Desired Skills:

  • Agility, audit management, business partnering, change control, continuous learning, health authorities, influencing skills, knowledge of CAPA, QA, quality management, quality management systems (QMS), risk management, root cause analysis (RCA), self-awareness, SOP, technological expertise.

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