R&D Quality Manager

3 weeks ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

Key Responsibilities:

- Managestechnical complaintsinvestigationsto determine root causes and implement corrective actions to prevent recurrence.
- Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events.
- Review and approve complaints as the site Investigation approver.
- Manage multiple investigations concurrently.
- Periodically analyze trends in technical complaints.
- Participate in audits and inspections, including inspection readiness activities.
- Handle data integrity escalations.
- Implement and drive global Data Integrity (DI) network initiatives

Essential Requirements:

- More than Over 10years of practical experience in thechemical/pharmaceutical industry or over5years of experience in pharmaceutical operations.In-depthknowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-.
- Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion.
- Experienced in cGMP manufacturing, Quality, and Compliance.
- Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking.
- Capable of completing routine tasks with minimal direction
- Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as well as medical devices, packaging and distribution related topics
- Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations.
- Excellent verbal and written communication skills.
- Project Management
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines

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