QC Specialist – Chemical Lab
- Execution of Project related tasks and daily routine operation of Physical and Chemical Analysis division of QC lab and coordination with QC Manager and other department for timely analysis, investigation and release of Incoming, in-process and finished goods samples.
- Sampling, analysis and release of raw materials, IPC samples, drug substances and drug products, ensuring all documented results are according to cGMP in respect of Chemical/ Analytical.
- Technology transfer of analytical methods to QC, Method verification & validation Test sample as per Schedule.
- Testing of all Stability samples on different conditions at different intervals as per ICH guidelines.
- Analysis of raw materials, bulk samples, finished products using HPLC, GC, UV Visible, and FTIR Instruments.
- Handling Incidents & Deviations in laboratory, OOT and OOS. Leads investigations and identifies root causes and appropriate corrective actions.
- Calibration of all Lab Instruments and Equipment is as per Standard Operating Procedures.
- Ensuring that all laboratory employees meet training requirements and work to ensure that the company is in compliance with all regulatory, environmental, health and safety requirements.
- Implement, perform, and coordinate with the QC personnel for all laboratory tests raw data and certificate of analysis for raw materials, in-process test data, and final product test results.
- Ensures the quality of testing in area of responsibility. Investigates testing quality issues and implements countermeasures to prevent reoccurrence. Documents abnormal conditions or quality issues and provides feedback to department head.
- cGMP, GLP implementation in daily operations of laboratory activity with emphasis on the documentation.
- Performs troubleshooting of instruments or other equipment’s if possible. Communicates and confirms with the Teammate that problem issue is understood before closing out the problem.
- To manager Quality management system activities for the Microbiology division (Change Control, CAPA, Risk, Customer Complaints, Root Cause Analysis, Interval/ external audits etc.
- Complies with all General Laboratory Practices (GLP), safety requirements, laboratory standard operating procedures.
- Support in performance qualification, validation studies and routine validation requirements.
Qualifications & Experiences
- Batchelor’s Degree in Pharmacy, Chemistry, Biotechnology, Biochemistry, or any related field.
- 8 Year in Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment. (3 years in multi-national Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment.)
- Business-Results Orientation
- Expert in Coordination, Collaboration and Influencing
- Acting with urgency
- Excellent Team Development
- Expert Intercultural Sensitivity
- Good command in English Language (Verbal and Written)
- Reporting and Presentation skills