Job Description
JOB DESCRIPTION:- 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 Development
DIVISION:EPD Established Pharma
LOCATION:India > Mumbai : BKC Building
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)
Job Details
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Job Location
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India
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Company Industry
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Other Business Support Services
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Company Type
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Unspecified
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Employment Type
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Unspecified
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Monthly Salary Range
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Unspecified
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Number of Vacancies
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Unspecified