Team Member – Technology Projects (Regulatory Affairs) | Cipla | Mumbai

Job Description

Job Purpose

Execute the implementation of the RA data system in the Regulatory Affairs department for effective document and workflow management execute the implementation of ELN in IPD for effective information management for simplification and improvement of throughput with compliance

Accountabilities

  • Collate and document the techno-commercial comparison of available new technology systems for further evaluation and decision-making by the Group Leader
  • Gather user requirements and prepare a document to comply with Computerized System Validation SOP and guidelines.
  • Collaborate with External vendors to design the system and further validation activities
  • Create Standard Operating Procedure for the new system and conduct training for implementation in the concerned function
  • Collate and facilitate legacy data migration to the new system and perform migration validation for implementation and smooth functioning of the system
  • Support the end user during the production phase by resolving queries during its operation and carry out system retirement for smooth integration of the new system into the existing one
Education Qualification

B.Pharm., M.Sc.(FOR ELN)

Relevant Experience:

Minimum 5 to 10 years of experience in functional knowledge (Analytical, Regulatory Affairs, etc.), and a Minimum of 2 to 5 years CSV experience in the Pharmaceutical Industry

Location