QC Specialist – Microbiology Lab
- Execution of Project related tasks and daily routine operation of Microbiological 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, in-process, bulk, samples and finished goods, ensuring all documented results are according to cGMP with respect to Microbiology.
- To perform QC analysis in accordance with microbiological best laboratory practices, qualification, validation studies and routine validation 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.
- Responsible for preparing testing procedures with the help of QC head and streamlining same in order to increase lab efficiency.
- 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. Leads investigations and identifies root causes and appropriate corrective actions.
- 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.
- Audits processes to ensure that Teammates are following the established standard work and Coaches the teammates if standard work is not being followed.
- To manager quality management system (QMS) activities for the Microbiology division (Change Control, CAPA, Risk, Customer Complaints, Root Cause Analysis, Interval/ external audits etc.
- Handling Incidents & Deviations in laboratory, OOT and OOS. Leads investigations and identifies root causes and appropriate corrective actions.
- Training of staff where appropriate and providing technical support to the teammates.
- 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.
- Introduction of new products, procedures and processes into the department or other departments.
- Complies with all General Laboratory Practices (GLP), safety requirements, laboratory standard operating procedures.
Qualifications & Experinces
- 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