Analytical method development and validation for all pharmaceutical dosage forms as per current compendial pharmacopoeias, ICH, global regulatory requirements.
Execution of analytical method transfer for pharmaceutical dosage forms.
Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPM' s) across globe.
Collaboration & participate meetings with multidisciplinary teams (Manufacturing, Supply Chain, Commercial, Quality Assurance and Regulatory Affairs) to provide scientific support to Product Evaluation, Formulation and Process Development.
Literature search related to the drug substance, create analytical profiles.
Analysis of routine samples (product development batches, stability study samples, raw materials etc.).
Operation and Calibration of analytical instruments/equipment’s.
Conducts lab investigations for OOS and OOT results
Data Review and Release (as assigned).
Documentation of analytical activities as per Good documentation practices.
Preparation of SOPs, STPs, Specifications, COAs and stability reports
Review of Analytical development & stability data.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Product DevelopmentDIVISION:EPD Established PharmaLOCATION:India > Mumbai : BKC BuildingADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
