IND
58 days ago
Manager
1. To prepare & execute metered dose inhaler (MDI) formulation development experiments **2.** To design pre-formulation and prototype experiments and to monitor batches prepared for stability studies, method development & validation. **3.** To prepare/review documents for import of API/Innovator sample and for manufacturing license for examination, testing & analysis of drug products. **4.** To ensure procurement of raw material (API/Excipients), packing material & innovator samples in consultation with packing/Purchase department. **5.** To evaluate Innovator pack details and review Innovator procurement quantity with justification. **6.** To prepare/review product development protocol & report for different development studies. **8.** To prepare/review test request for analysis of raw material (API/Excipients) & drug product. **9.** To prepare/review stability protocol & report. **10.** To prepare budget of assigned project. **11.** To prepare/review tech-transfer documents (e.g.sheet II, MF, RA, FMEA, stability plan, scale up report and SDS) 12. To support in execution of scale up /exhibit /clinical batches at plant/CMO 13. To prepare/review documents required for regulatory submission for all markets & to prepare/review technical reports/scientific justification to respond regulatory queries. 14. To prepare/review SOPs for laboratory equipment/instrument. 15. To prepare/review troubleshooting/investigational reports for failures/OOS/OOT. 16. To ensure compliance of internal quality system We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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