Amneal Pharma Hiring For ARD/ R&D - Documentation / Analytical Development- Injectable Scientists

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"