Job Description

To request/generate RM code, project code, product code.

• To apply for licenses for import of API/Innovator sample, for manufacturing license for examination, testing & analysis of drug products.

• To initiate procurement of raw material (API/Excipients), packing material & innovator samples in consultation with packing/purchase department.

• To prepare batches for pre-formulation, prototype, stability & method development & validation.

• To enter experimentation details in Log book/ELN.

• To prepare product development protocol for different development studies as per checklist, its execution & preparation of report.

• To prepare test request for analysis of raw material (API/Excipients) & drug product.

• To prepare stability protocol & submit samples to charge on stability.

• To prepare tech-transfer documents (e.g.sheet II, MF, RA, FMEA, stability plan & SDS).

• To supervise scale up / exhibit / clinical batches at plant/CMO.

• To prepare documents required for regulatory submission for all markets & to prepare technical reports/scientific justification to respond regulatory queries.

• To propose in-process & finished product specification.

• To prepare narcotics & psychotropic substance related documents (If used).

• To prepare SOPs for laboratory equipment/instrument.

• To be a part of equipment / instrument qualification activity in case of procurement of any new equipment / instrument and prepare/ review qualification documents.

• To use different applications introduced by management as a part of IT enablement.

• To participate in different management initiatives like PACE, Kaizen & process excellence.

• To follow defined internal quality systems.