Key Accountabilities and Responsibilities:

· Analytical Method Development of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

· Analytical Method Validation of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

· Analytical Method Transfer of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

JOB SPECIFICATION

• Analytical method development and validation for pharmaceutical dosage forms.
• Literature search related to the drug substance, create analytical profiles.
• Execution of analytical method transfer for pharmaceutical dosage forms.
• Analysis of routine samples (product development batches, stability study samples, raw materials etc.).
• Operation and Calibration of analytical instruments/equipment’s.
• Qualification of working standards.
• Data Review and Release (as assigned).
• Documentation of analytical activities as per Good documentation practices.
• Work in laboratory as per Good laboratory practices.
• To use PPEs and follow safe practices in lab.
• Preparation of SOPs, STPs, Specifications, COAs and stability reports
• Preparation of RM Specification and STPs
• Trouble shooting of analytical issues/problems/queries.
• Review of Analytical development & stability data.
• Analytical Activities related to Quality Control Department.
• Any other task assigned by management.

Competencies Required:

• Good Knowledge about Analytical Method development, Validation and method transfer
• Knowledge about the Regulatory requirement and Quality requirement
• Must be able to perform the analysis as per the Good Laboratory Practices

Functional Skills/ Know-how:

• Hands on experience on HPLC, GC, UV spectrophotometer, IR spectroscopy, Dissolution Test Apparatus, Disintegration Test Apparatus, Viscometer, Differential Scanning Calorimetry (DSC), Malvern Particle sizer.