Research Associate - Process Research Analytics (API)

RESPONSIBILITIES

• Prepare literature search.
• Responsible for maintaining Lab note books, Log books and other documentation.
• Responsible for preparation of specification and test procedure for raw material, in process check, intermediate and drug substance as per ICH guidelines.
• Ensure support for method development and routine testing samples.
• Monitoring general laboratory and its maintenance activity as applicable.
• Responsible for troubleshooting and maintenance of HPLC, GC, UV/Visible and spectrophotometer etc.
• Prepare and maintain related SOPs/Formats/Protocols/Reports/Manuals as per the requirement
• Preparation of CoAs.
• Following in house systems and procedures to ensure cGMP practices and regulatory requirements.
• Handling of Troubleshooting.

DESIRED SKILLS

• Must have experience in formulation testing in reputed pharma organizations
• Knowledge of different pharmacopeial guideline is desirable.
• Experience in handling of instruments like HPLC, GC, UV, UPLC, Dissolution tester, KF, FTIR.
• Strong technical presentations skills
• Good Communication and problem solving skills
• Should be assertive, proactive and self-driven
• Should be willing to work in a dynamic work environment