Senior Executive

SUN PHARMA

0 years

0 Lacs

Vadodara Gujarat India

Posted:1 day ago| Platform:

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Skills Required

code api manufacturing testing analysis procurement prototype stability development experimentation test fmea reports management kaizen

Work Mode

On-site

Job Type

Full Time

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.

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