Amneal Pharma Hiring For ARD/ R&D - Documentation / Analytical Development- Injectable Scientists
Amneal Pharma Hiring For ARD/ R&D - Documentation/ Analytical Development- Injectable Scientists |
1) We at Amneal have opportunity for Analytical Development - QMS/ DQA (Documentation) based at Ahmedabad location. Request to find below the required details:
Job Profiles: ARD/ R&D - Documentation
Required Experience: 04-10 Years
Position: Executive / Senior Executive
Job Location: Ahmedabad
Job Description For Amneal Pharma
1 Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product) Review of DMF to prepare Analytical method and specification. Preparation of justification of specification and characterization report.
2 Preparation of analytical reports (like Equivalency, Investigation study, Reconstitution study or dilution study, Elemental Risk
3 Assessment Report, Nitrosamine Impurity Risk assessment)
4 Preparation of Documents for form 29 Applications.
5 Good understanding for Impurity profiling.
6 Well versed with current agency requirement.
7 Well versed with ICH quality guidelines
8 Good knowledge for Pharmacopoeia Good communication especially writing skills for preparing quality documents and coordination with Cross functional team
If interested, please share your CV
at kavitriy@amneal.com mentioning the subject line "Application for ARD-Documentation"
2) We at Amneal have opportunity for Analytical Development- Injectable Scientists based at Ahmedabad location. Request to find below the required details:
Job Profiles: Characterization Group (Peptide Characterization)
Required Experience: 05-10 Years
Position: Executive / Senior Executive
Job Location: Ahmedabad
Job Description:
1 Proven Experience of working in GMP/ GLP and scientific environment.
2 Basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, peptide and Complex injectable product development and peptide characterization (any one of the Area).
3 Experience in related compound and assay method development, validation using Amino acid analyzer, HPLC, UPLC,
4 GC for Peptide and complex products.
5 Experience in related compound method development and method validation for Peptide drug product using LC-UV/RI and LC-HRMS for Peptide and complex products.
6 Hands on Experience of using SEC/GPC, SEC-MALS, SV-AUC, DLS and data interpretation
7 Experience in Preparation and review of method development, method validation, submission reports.
8 Knowledge of ICH guidelines and regulatory requirement for peptide and complex injectable product and experience in scientific writing will be plus.
If interested, please share your CV
at kavitriy@amneal.com mentioning the subject line "Application for ARD- Characterization"
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