Quality Control Analytical Executive

Executive - QC Analytical

Job Description

1. Timely testing with online documentation of various sample stages including in-process, intermediate, drug substance/ drug product, stability samples of Biotherapeutics proteins for test parameters including but not limited to HPLC methods, Host cell DNA contaminants quantification by RT PCR, Host cell protein contaminants quantification by ELISA, Electrophoresis, ELISA based assays and general procedures including but not limited to extractable volume, sub-visible particle testing, pH, conductivity. Should work in shifts.
2. Preparation of reagents/ solutions required for routine testing and maintenance of their records.
3. Preparation and periodic updation of SOPs, STPs and Specifications pertaining to testing of Biotherapeutics.
4. Perform In-house calibration/ verification of Analytical equipment as per the approved procedures and calibration/ verification frequency. Online monitoring and maintenance of equipment records.
5. To ensure cGMP compliance and maintain the laboratory in audit ready condition. To report any Deviations/ Out of Specifications results and Safety risks to the supervisor as and when observed.
6. Participation in transfer of analytical methods from R&D to QC.
7. To attend all GMP/ On-job/ additional trainings as per the approved training matrix and update the training records.

Work Experience

Education

Competencies

Innovation & CreativityResult OrientationCollaborationCustomer CentricityDeveloping TalentStakeholder ManagementStrategic AgilityProcess Excellence

Experience Level

Executive Level