Executive - Quality Control

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Executive - Quality Control
Job Description
JD - Executive (Microbilogist)
Ensure effective functioning of Microbiology Laboratory by carry out analysis
Ensure the compliance to cGMP regulations, quality guidelines and local SOPs.
Ensure online documentation.
Planning and execution of Microbiological activities & online documentation.
Microbiological testing of finished product, starting material, stability sample, R & D sample.
Microbiological media preparation and its GPT.
Daily monitoring of Area / room & refrigerator/ Incubators temperatures,
Microbiological monitoring of classified areas.
Bacterial culture maintenance and keeping records of consumption of ATCC/NCTC cultures.
Sampling & Analysis of water samples for microbiological parameters.
Analysis of compressed air and nitrogen gas.
Report all deviations, which may have impact on safety, identity, strength, purity & quality of drug substance/ product.
Issuance of QC analytical data sheets
Trending & review of microbial analytical data for water samples, RM, FG samples.
Monitoring & perform the calibration / validation for Instruments / Equipment in micro-Lab.
Preparation and destruction of Media and culture.
Preparation of Microbial inoculum.
To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs
To ensure work permit system during maintenance activities.
To perform Autoclave validation.
To carryout in-house Microbial flora isolation process.
To perform fogging activity as per schedule.
Daily review & prints out of Incubator when it required.
To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
To perform Microbial assay.