Are you a passionate professional with a background in Quality Assurance, Regulatory Affairs, or Pharmaceutical Manufacturing? Novartis, a global leader in healthcare, is seeking a Specialist – Quality Operations to join their team in Hyderabad. This is an excellent opportunity to contribute to a company that is reimagining medicine to improve and extend people’s lives.
About the Role
As a Specialist – Quality Operations, you will play a critical role in ensuring compliance with cGMP requirements and the Novartis Quality Management System. You will manage quality aspects and projects, collaborate with global stakeholders, and support regulatory requirements. This position offers a chance to work in a dynamic environment where your contributions will directly impact patient safety and product quality.
Key Responsibilities
- Coordination and Management: Oversee analytical method transfers, stability studies, and compile data reports.
- Life-cycle Management: Manage analytical methods, ensuring compliance with pharmacopoeia and health authority standards.
- Deviation Handling: Investigate and resolve deviations, OOS/OOE/OOT cases, and manage changes and complaints.
- Data Analysis: Perform statistical data analysis to identify trends and report Out of Expectations (OOE) and Out of Trends (OOT).
- SAP Master Data Management: Maintain master data, create Q-info records, and handle SAP-related activities.
- Documentation: Author, review, and archive GxP documents, including SOPs, qualification reports, and technical investigations.
- Regulatory Support: Assist with routine regulatory queries, chromatogram requests, and compilation of registration documents.
- Quality Performance Management: Trend and report Quality Management System (QMS) elements and compile quality performance decks.
- Compliance: Implement GMP requirements and ensure adherence to Novartis Quality Standards.
Essential Requirements
- Educational Background: Pharmacy, Science, MBA, Engineering, or equivalent from a reputed institute.
- Experience: Minimum 3 years in Quality Assurance, Regulatory Affairs, or pharmaceutical manufacturing.
- Technical Skills: Strong knowledge of GxP, basic IT skills, and experience with SAP and LIMS systems.
- Soft Skills: Excellent communication, presentation, and interpersonal skills.
- Global Collaboration: Experience working with global stakeholders in a cross-functional environment.
Why Novartis?
At Novartis, our purpose is to reimagine medicine to improve and extend people’s lives. We aim to become the most valued and trusted medicines company in the world, and we believe our people are the driving force behind this mission. By joining Novartis, you will be part of a culture that fosters innovation, collaboration, and professional growth.
This role is ideal for professionals with:
- A background in Quality Assurance, Quality Operations, or Pharmaceutical Manufacturing.
- Experience in managing analytical methods, deviations, and compliance with cGMP.
- An interest in supporting regulatory requirements and collaborating with global stakeholders.
