Pharmazz India is hiring for Analytical Research Associate / Manager Role
Designation : Research Associate /Manager
Experience: 2 – 4 years of relevant experience.
Educational Qualification: Post Graduate (Analytical Chemistry / Organic Chemistry) or M. Pharm (Pharmaceutical Analysis)
Location : Greater Noida, Uttar Pradesh
Package Based on Experience and Interview.
- Handing, maintaining and troubleshooting of Analytical/ scientific instruments (Weighing balances, HPLC, UV, KF, IR, pH meter, LC-MS)
- Analytical method development/validation for assay and impurity methods.
- Identification, qualification, and quantification of impurities in drug substances and drug products using Analytical techniques as per ICH.
- Knowledge of regulatory guidelines (US FDA, EU, Schedule Y), ICH, USP, BP, IP.
- Handling Stability requirement of pharmaceutical DS and DP as per ICH.
- Preparation and review of Analytical SOPS, STPS and Lab manuals, study reports, stability protocols and summary.
- Handling projects independently with minimal supervisor.
- Planning and execution of Analytical projects.
- Answering regulatory queries related to DS and DP.
- Conducting audits at CMO sites.
- Maintain inventory of lab supplies, chemicals, excipients, DS and DP.
- Tech transfer of Analytical and manufacturing related procedures to CMO sites.
- Experience of working in GLP environment. Assisting regulatory team in preparation and review of CMC modules for eCTD. – Maintain records of daily work and participate in lab meetings.
- Experience in handling NCE projects, injectables, lyophilized products, peptide products. – Maintain confidentiality of company information / records / reports.
- Maintain healthy environment and work culture.
Application Process : Interested & Eligible Candidates send your CV to pharmazz hr Mail id : firstname.lastname@example.org