JOB TITLE
Executive/Sr. Executive, Quality Control, Pharmaceuticals
Job Purpose
Generic
Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers requirements, living Group's Values and Code of Ethics.
Requirements
Education / Experience
Post Graduate in Science (Organic or Analytical Chemistry )
2-5 years in a Pharmaceutical Company.
Technical Skills &
Competencies / Language
- Analytical ability
- Trouble shootings
- Co ordination
- Communication
Key Accountabilities
Testing
Performing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.
Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals.
Testing on nitrosamine and related impurities.
Good Laboratory Practice
Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
Reviewing pharmacopeias for specification preparation.
Preparing SOPs and Formats and Analytical Test Record.
Managing reference standards, working standards, laboratory reagents & chemicals.
Arranging and observing Control Samples and maintaining record.
Participating in Investigation of out of specification results, retesting and review the analysis records.
Maintaining & reviewing laboratory raw data related to testing activity.
Validation
Preparing protocol for Analytical Method validation/verification & transfer, cleaning validation and performing the validation exercise as per the protocol for the material and drug products.
Performing analytical method validation/verification & transfer for nitrosamine and NDSRIs using LCMS/MS
Analytical method development and related troubleshooting samples on LCMS/MS.
Management of laboratory Consumables
Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material.
Co ordination
Coordinating with production, and warehouse for analytical activities.
Other
Compliance to HSE Requirements for QC Laboratory
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
