Job Description

JOB DESCRIPTION:
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.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Product Development
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : Mumbai Development Center - EPD
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Skills Required