Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Job Description
The role involves operating advanced analytical instruments such as HPLC, GC, and ICP-MS for testing raw materials, finished products, and dosage forms. The incumbent will ensure compliance with Good Laboratory Practices (GLP), perform data analysis, and maintain accurate documentation. Additional responsibilities include participating in investigations, raising procurement requests, conducting method transfers, and supporting continuous laboratory development through training and adherence to SOPs.
Essential Functions
- Perform analytical method development (Related Substances, Assay, Dissolution, Residual Solvents, etc.) for development projects using instruments such as HPLC, IC, GC, and Particle Size Analyzer.
- Prepare method development reports along with tentative analytical methods.
- Execute method transfer activities.
- Conduct analytical method validation (Dissolution, Assay, Related Substances, Residual Solvents, etc.).
- Prepare Technology Transfer (TT) reports.
- Maintain cleanliness and comply with Good Laboratory Practices within the laboratory.
- Prepare laboratory study protocols.
- Perform development batch stability analysis as per approved stability protocols.
- Complete self-training requirements through QMS.
- Prepare and release Certificates of Analysis (COA) for development samples against TRF.
Additional Responsibilities
- Raise indents, prepare CAPEX justifications, and manage laboratory inventory.
- Attend technical workshops/seminars and explore new techniques and technologies applicable to the workplace.
Qualifications
Education
- Master’s Degree (M.Sc.) – Preferred
- Master’s Degree (M.Pharm) – Preferred
Experience
- 5–7 years of relevant experience in Analytical R&D / Method Development.
Skills
- Documentation, Data Review, Interpretation & Statistical Analysis – Intermediate
- Analytical Method Development & Validation – Intermediate
- Good Laboratory Practices (GLP), Data Integrity & Compliance – Advanced
- Stability Study Management – Advanced
- Good Documentation Practices (GDP) – Intermediate
- Electronic Lab Notebook (ELN) / LIMS Management – Advanced
- Adaptability to Organizational Growth – Intermediate
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