Company Jobs

Prepare and review Batch Manufacturing Records BMR and Batch Packaging Records BPR, Master Formula Records MFR.

Handling of batch manufacturing and filling activity with regulatory exposure in Sterile area.

Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems. Ability to work both independently and collaboratively.

Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA) / brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts

The incumbent will support the formulation development team for development of cosmetics and commodity products. Work collaboratively with internal and external stakeholders to meet the development timelines.

Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities.

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.

Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.

Forecast Platform Specialist works closely with the GCS Forecasting CoE/ GIBEx/ GA&I teams as well as the Platform vendor team in deploying the cloud-based forecasting platform.