Opportunity to work as Quality Operations Specialist at Novartis

Novartis is indeed renowned for its exciting product pipeline and its commitment to developing innovative medicines. The company’s dedication to advancing healthcare and improving patient outcomes is supported by a diverse and talented workforce. Novartis recognizes the importance of its employees and strives to create a performance-driven environment.

Position: Specialist – Quality Operations

Job Description: As a Specialist in Quality Operations, you will be responsible for delivering high-quality services to support product quality compliance and regulatory workflows. Your key responsibilities will include:

1. Workflow Management: Utilize various workflow applications such as SAP, Dragon, SUBWAY, TEDI, etc., to manage accounts and ensure the proper execution of service deliverables.
2. Issue Escalation and Compliance: Identify and escalate any GxP (Good Practice) and non-GxP issues, ensuring timely investigation and compliance with local and global operating procedures. Support the implementation of service quality and process improvement projects and effectively manage CAPA (Corrective and Preventive Actions) within the Quality Service Centers.
3. Data Compilation and Reporting: Extract and compile analytical, manufacturing (including deviations, complaints, and change requests), and regulatory data in a predefined format. Collect stability data and reports for product-related evaluations and support the maintenance of APR/PQR (Annual Product Review/Product Quality Review) schedules.
4. Complaint Handling: Track complaint samples from the Country Organization (CO) to the Contract Manufacturing Organization (CMO). Send technical complaints to CMO for investigation. Perform queries in AQWA/Trackwise as per the Standard Operating Procedures (SOPs). Perform quarterly compliant trending and reporting. Act as a QA (Quality Assurance) approver for customer complaints delegated to QSC (Quality Service Centers) through delegated action.
5. Change Control Management: Serve as a change control coordinator or change phase manager in systems like TrackWise and AGILE. Manage different types of change control, including product stewardship, administration stewardship, and asset stewardship.

Requirements:

• Bachelor’s degree in a relevant scientific discipline or a related field.
• Previous experience in quality operations or a similar role within the pharmaceutical or healthcare industry.
• Strong knowledge of regulatory requirements and quality compliance.
• Familiarity with workflow applications such as SAP, Dragon, SUBWAY, TEDI, etc.
• Excellent problem-solving skills and the ability to escalate and investigate issues effectively.
• Proficiency in data compilation, analysis, and reporting.
• Familiarity with complaint handling processes and systems.
• Knowledge of change control management systems like TrackWise and AGILE.
• Strong organizational skills and attention to detail.Candidate Profile:
  • Education: The ideal candidate should possess an M.Pharm, MBA, Engineering degree, or an equivalent qualification from a reputed institute.
  • Experience: A minimum of 5 years of experience in Quality Assurance, Regulatory, or in the manufacturing of pharmaceutical drug substances/products/medical devices. The candidate should have a strong understanding of GxP (Good Practice) principles and broad IT knowledge.
  • Communication and Interpersonal Skills: Good communication, presentation, and interpersonal skills are essential for this role. The candidate should have experience working closely with global stakeholders.
  • Knowledge and Expertise: Experience with MAH (Marketing Authorization Holder) review, quality compliance management, technical learning and document management systems, product release support, and stability support services is highly desirable.
  • Location: The position is based in Hyderabad.
  • Industry Type: The industry type is pharmaceutical.
  • Functional Area: The candidate will be working in the Quality department.
  • End Date: The application deadline for this position is 20th July 2023.For more articles, Kindly Click here.For pharmaceutical jobs, follow us on LinkedIn

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