About this role
The Senior Executive Quality Control role at Abbott involves leading analytical activities in the pharmaceutical lab at Baddi, India. Responsibilities center on performing chemical and instrumentation analyses per the Analytical competency matrix (Format No.BDI-QCSG004F23) and on-job training (Format No.BDI-QCSG004F19). This position ensures timely execution under GLP and GMP standards.
Day-to-day duties include analysis of in-process, SFG, finished goods, raw materials, and stability samples for OSD and LVP. Conduct analytical method validation/verification as per defined protocols, with related documentation. Manage sample receipt, SAP data entry, and coordination with outside commercial labs.
In the Quality Control department, calibrate instruments, prepare volumetric solutions, reagents, and test solutions as required. Maintain resources and update documents per pharmacopeial amendments. Ensure compliance with cGMP/cGDP, data integrity, and EPD Global Guidelines.
Face internal and external audits, implement GLP/GMP requirements, and align practices with COBC. Complete SOP training in Isotrain within stipulated time and handle tasks assigned by the reporting manager. In absence, subordinates or designees manage daily operations.
Requirements
- Proficiency in chemical and instrumentation analysis per competency matrix
- Knowledge of analytical method validation and verification for OSD and LVP
- Experience with sample analysis including stability and raw materials
- Familiarity with SAP for data entry
- Skill in instrument calibration and solution preparation
- Understanding of pharmacopeial amendments and document updates
- Ability to ensure GLP/GMP/cGMP compliance and data integrity
- Preparedness for internal and external audits
Responsibilities
- Perform analytical activities as per Analytical competency matrix and on-job training for chemical and instrumentation
- Analyze in-process, SFG, finished goods, raw material, and stability samples
- Conduct analytical method validation/verification for OSD and LVP as per protocol
- Receive samples and manage their documentation
- Enter data in SAP
- Send samples to outside laboratories and ensure analysis as required
- Calibrate instruments and prepare volumetric solutions, reagents, and test solutions
- Ensure compliance with cGMP/cGDP, data integrity, and EPD Global Guidelines
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