Manufacturing documentation and Technology Transfer

Role & responsibilities

• To work in collaboration with US team members to create the highest quality documents and timely delivery of outputs consistently.
• Prepare and review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules (for submission/validation batches).
• Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVRs) in addition to timely monitoring of Annual Cleaning Verification Program, DEHT & CEHT.
• Handling of CC, UD, PD, Event and Customer complaints as and when required.
• To prepare and review documents for manufacturing activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing related documents.
• Prepares technical assessment reports and deviations investigations, etc.
• Ensure training completion as per assigned curriculum.

Preferred candidate profile

Manufacturing Batch Record, Process Validation, Regulatory Modules, Bulk Hold Time, Site Transfer, Scale Up, Process Engineering Batch documentation and QMS with Good communication skills and interpersonal skills. Good team player