Amneal Job Vacancy For B.Pharm/ M.Pharm/ MSc
We are urgently hiring for Mgr./Sr. Mgr. / AGM for SETE-SIE (Strategic International Expansion) at Amneal Pharma,Ahmedabad.
Qualification: B.Pharm, M.Sc.,M.Pharm
Designation : Manager/Sr.Manager/AGM
Yrs. of Experience : 8-12 Yrs.
Key Responsibilities:
Team handling, work allocation, delegation, routine work distribution,
Extensive US CFTS communications to resolve day-to-day work assignments Should have sound knowledge of all areas of R&D, Quality, Mfg, which includes but not limited to following:
1. Writing and reviewing analytical methods, specifications,vendor qualifications, USP monograph evaluations, analytical method validation protocols and reports
2. CGMP/ Quality documents like, MBR, Stability, Special study, Process and other study protocols, change controls etc.
3. Prepare Process Validation Protocol, Cleaning Validation Protocol, Blend Bulk Hold Time study protocols, Change Control Assessment
4. Change control Management including evaluation and approval of change controls.
5. Understanding its impact assessment on product quality and regulatory compliance.
6. Well verse with FDA's current requirements.
7. Complete awareness of 21 CFR Part 210 and 211 compliance.
Interested candidate can drop CV @
Mentioning Subject Line as: SETE-SIE-Lead
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