Novartis is seeking a R&D Quality Manager for their office in Hyderabad. The company boasts a robust and innovative product pipeline, offering a dynamic and rewarding environment for professionals in the pharmaceutical and healthcare sectors.
Job Description
The R&D Quality Manager will handle and manage technical complaints related to Investigational Medicinal Products (IMPs) and Medical Devices. The responsibilities include:
- Conducting and leading technical complaint investigations to identify root causes and implement corrective actions.
- Collaborating with cross-functional teams to collect data and perform Root Cause Analysis (RCA).
- Acting as the site Investigation approver by reviewing and approving complaints.
- Managing multiple investigations simultaneously.
- Analyzing technical complaint trends periodically.
- Participating in audits, inspections, and contributing to inspection readiness.
- Addressing and managing data integrity escalations and contributing to global Data Integrity (DI) initiatives.
- Implementing global DI network projects and maintaining compliance.
Candidate Profile
- Experience: More than 10 years in the chemical/pharmaceutical industry, or over 5 years in pharmaceutical operations.
- Skills:
- Proficiency in conducting Root Cause Investigations and collaborating effectively with teams.
- Knowledge of cGMP manufacturing processes, quality, and compliance standards.
- Strong problem-solving, analytical, project management, and conflict management skills.
- Ability to handle investigations related to various pharmaceutical products and devices.
- Excellent communication (both written and verbal).
- Thorough understanding of international regulatory regulations and cGxP requirements, including EU-GMP guidelines.
Additional Details
- Location: Hyderabad (Office-based)
- Industry: Pharma/Healthcare/Clinical Research
- Division: Development
- Business Unit: Innovative Medicines
- Application Deadline: 30th November 2024