Manager

SUN PHARMA

0 years

0 Lacs

Vadodara Gujarat India

Posted:1 week ago| Platform:

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Skills Required

development design prototype stability api manufacturing testing analysis procurement report test fmea support reports troubleshooting compliance

Work Mode

On-site

Job Type

Full Time

Job Description

To prepare & execute metered dose inhaler (MDI) formulation development experiments
To design pre-formulation and prototype experiments and to monitor batches prepared for stability studies, method development & validation.
To prepare/review documents for import of API/Innovator sample and for manufacturing license for examination, testing & analysis of drug products.
To ensure procurement of raw material (API/Excipients), packing material & innovator samples in consultation with packing/Purchase department.
To evaluate Innovator pack details and review Innovator procurement quantity with justification.
To prepare/review product development protocol & report for different development studies.
To prepare/review test request for analysis of raw material (API/Excipients) & drug product.
To prepare/review stability protocol & report.
To prepare budget of assigned project.
To prepare/review tech-transfer documents (e.g.sheet II, MF, RA, FMEA, stability plan, scale up report and SDS)
To support in execution of scale up /exhibit /clinical batches at plant/CMO
To prepare/review documents required for regulatory submission for all markets & to prepare/review technical reports/scientific justification to respond regulatory queries.
To prepare/review SOPs for laboratory equipment/instrument.
To prepare/review troubleshooting/investigational reports for failures/OOS/OOT.
To ensure compliance of internal quality system

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