Job Description
Department: QC-Microbiology
Vacant Position: Executive / Sr. Executive
Type of Experience: Exposure to Environmental Monitoring & Basic analytical techniques such culture handling & media preparation. (Sterile/ Injectables or Parenteral experience is mandatory)
Minimum Years: 4 to 8 Years of Experience in Sterile
KEY DUTIES AND RESPONSIBILITIES:
- To perform sampling and microbiological testing of water and timely documentation as per relevant current procedures.
- To perform sampling and microbiological enumeration testing of raw material, In-process, finished, semi-finished, stability samples (but not limited to) and timely documentation as per relevant current procedures
- To perform sampling and bacterial endotoxin testing of raw material, In-process, finished, semi-finished, stability samples (but not limited to) and timely documentation as per relevant current procedures
- To perform sampling and sterility testing of raw material, In process, finished, semi-finished, stability samples (but not limited to) and timely documentation as per relevant current procedures
- Review qualification and calibration reports of analytical instruments for its completeness, accuracy and data integrity elements.
- Review and approve (wherever applicable) all documents that are generated by the individual team members for accuracy, adequacy completeness and data integrity elements.
- To perform data trending analysis for EM/water/compressed gases (but not limited to) and timely completion and approvals.
- To perform microbiological testing of Container integrity testing and timely documentation as per relevant current protocols
- To perform microbiological testing of Disinfectant efficacy test and timely documentation as per relevant current protocols.
- To perform Miscellaneous validations, transfer validations, hold time studies (but not limited to) and timely documentation as per relevant protocols
- To perform analytical method validations like Sterility test, microbiological contamination test, bacterial endotoxin testing, microbiological assay for product/material (but not limited to) and timely documentation as per relevant current protocols.
- To perform data trending analysis for EM/water/compressed gases (but not limited to) and timely completion and approvals.
- To execute viable environmental monitoring programme as per defined frequency and timely documentation as per relevant current procedures.
- To execute compressed gases/Product contact gases sampling and timely documentation as per relevant current procedures.
- To perform gowning qualification/requalification and timely documentation as per relevant current procedures.
- To perform appropriate incubation, transfer, observation and result recording of samples and timely documentation as per relevant current procedures.
- To identify isolates and timely documentation as per relevant current procedures.
- To ensure calibration of sampling devices used for EM sampling and timely documentation as per relevant current procedures.
- To perform visual inspection of media filled units and timely documentation as per relevant current procedures.
- To execute viable environmental monitoring program as per defined frequency and timely documentation as per relevant current procedures.