Executive - QC (Micro)
Job Description
Competencies
Purpose of Job
Analysis of batch, water, EM and Microbial samples with proper documentation.
Method transfer and method validation activities along with proper documentation as per approved Protocols and SOPs.
Verification/ Calibration/ Qualification/ Monitoring/ Cleaning activities of various QC instruments/ equipment as per schedule.
Skill Required
Execution of batch, water, EM and Microbial samples.
Execution of Cell & gene therapy analytical techniques.
Execution of HCD/ELISA/molecular biology based techniques
Execution of HPLC based techniques
Execution of invitro bioassay analysis
Roles and Responsibilites
1. Training on cell & gene therapy analytical techniques, calibration / verification of equipment and SOP’s (general, calibration and operation).
2. Analysis of batch, water, EM and Microbial samples with proper documentation
3. Method transfer and method validation activities along with proper documentation as per approved Protocols and SOPs.
4. Maintenance of cell lines/ banks, Environmental Monitoring (Bio-Bulk Manufacturing and Finished Product Area), Monitoring of clean rooms/ gases.
5. Verification/ Calibration/ Qualification/ Monitoring/ Cleaning activities of various QC instruments/ equipment as per schedule.
6. QMS documentation and support in investigation
7. Preparation and revision of documents as and when required.
Qualification Required
M.Sc, M pharm, M. tech,
Relevant skills / Industry experience
Execution of batch, water, EM and Microbial samples.
Execution of HCD/ELISA/molecular biology based techniques
Execution of HPLC based techniques
Execution of invitro bioassay analysis