B.Pharm

Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches

In-Process, FG and Stability, Analytical Instrumentation - HPLC, UV and Dissolution

Ensure review of Stability sample analysis, In-Process testing, Technology Transfer, and review, release of Exhibit Finished Product reports. Approve Stability trends to ensure product quality and consistency.

D.Pharm, B.Pharm, M.Pharm with Gujarat State Pharmacy Council Drug License.

Candidate should have knowledge of packing operations. Knowledge of BQS, Autocarnator and Bottle packing. Responsible to adherence cGMP guidelines.

Monitoring and technical support for execution of Packing equipment qualification,Trial, Scale up, exhibit, commercial process validation batches on packing lines and handling of investigations, if any during the execution.

With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.

Autonomous with strong self-motivation and ability to work independently as well as in a highly collaborative and multicultural environment within short timelines.