Alkem Laboratories Ltd.
Website:
alkemlabs.com
Job details:
About Alkem:
Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.
Roles and Responsibilities
- Optimization of the Quality Assurance function, ensuring that the pharmacovigilance (PV) & clinical trial (CT) activities are conducted in compliance with internal procedures, regulatory requirements and industry standards.
- Development of policies/SOPs for quality assurance activities of PV & CT.
- Development of risk based strategic and tactical audit plan as required.
- Plan and conduct internal PV system audit, affiliates audit, licensing partners audit and service provider audit in support of global PV activity for post marketed and clinical development products, to assure compliance with the US Code of Federal Regulations, EU Directives, local regulations, ICH and Alkem policies and procedures.
- Plan and conduct internal audit of clinical research team and audit of clinical trial at investigator site in support of clinical development products for Phase 3 and 4, to assure compliance with the US Code of Federal Regulations, EU Directives, local regulations, ICH and Alkem policies and procedures.
- Support to facilitate timely PV and CT audit responses and evaluate proposed corrective actions, and/or preventative actions, including effectiveness checks for compliance with applicable regulations, guidelines, and Alkem policies and procedures.
- Support for global inspection activities, including inspection preparation and inspection management, in close collaboration with Corporate Quality Assurance and Compliance team.
- Support in the preparation, hosting and follow-up audits from licensing partners. Provide audit response and CAPA to the licensing partners.
- Support the ongoing development and operational success of the medical quality assurance functions.
- Ensuring the reports and appropriate (corrective and/or preventive) actions are developed and completed within timelines mandated in internal procedures
Education Qualification - Master’s degree or equivalent within Pharmacy, science or similar
Years Of Experience - 2-5 years of experience working in a Pharmaceutical or CRO setting (or equivalent); with mandatory GCP/PV auditing experience
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