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
Medical, Access, Value, PACE, Legal, Compliance Community, Legal, People & Culture, Regional and IQM team, PDQA team.
Along with PV & MAP SME, Direct Markets (Sri- Lanka, Nepal, Bhutan), Business Partners managing products or marketing of brands for Roche India, Distributors & CFA’s, Service Providers for Medical Function (including GCP and PV service providers), external audit group / SP
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
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
Roche Pharmaceuticals, India, has been disseminating scientific knowledge pertaining to innovative medicines to the medical fraternity.
We have products in therapeutic areas such as Oncology, Virology, Nephrology, Transplantation, Anemia... Not translated Arthritis.
In recognition of its contributions in Oncology, Roche India has been awarded the â€ Best Oncology Company of the Year,' by Frost & Sullivan at the India Healthcare Excellence Awards for the years 2011, 2012 and 2014. Not translated
Roche is an equal opportunity employer.