Require Assistant Manager at Roche

Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

Post : Assistant Manager - Quality (GCP & PV)

Job Description:
• To lead the QMS initiative for the Indian affiliate in managing compliance, training, audit/ inspection readiness for medical (GCP & PV), MAP teams & aligning QMS at the Indian affiliate with the global best practices of Roche.
• Monitor Regulations, processes/ procedural documents, Compliance Metrics, Training, systems, tools
• Monitor, prepare & coordinate for Audits/ Inspections & post conduct actionable (for Affiliate and Direct Markets)
• Report changes to ensure processes updated/ aligned where required
• Report Deviations to processes and relevant actionable to prevent
• Report product / data quality issues & Monitoring & evaluation of process/ program effectiveness
• Risk Assessment, Mitigation plans
• Build compliance, implementing learning from other affiliates
• Driving collaboration through establishment of a strong connect with Internal stakeholders to drive collaboration

Functional Competencies
• Knowledge of quality management systems
• Knowledge of Roche (GCP- PV) processes, procedural documents and tools
• Knowledge of GCP&PV
• Knowledge of Clinical Project Management
• Knowledge of Health Authority Requirements

Behavioural Competencies
• Collaboration / fostering teamwork, establishing focus
• Exhibition of Roche Leadership Competencies and Roche Core Values
• Provide guidance / implementable solutions via Analytical thinking
• Exhibit Quantum self
• Patient centricity in decision making
• Critical & Detailed Evaluation
• Unbiased & accurate reporting
• Learn & implement Ethical practices

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality (GCP & PV)
End Date : 5th March, 2019