Executive - Quality Control

piramalpharma; Mahad; On-site; INR 450,000 - 650,000; Full time

Job summary

Piramal Pharma Solutions is hiring an Executive - Quality Control in Maharashtra. The role involves ensuring microbiology analyses, cGMP compliance, and documentation across the QC lab. You will plan and execute microbiological activities, manage media preparation, sample testing, and instrument calibration.

The position requires strict adherence to SOPs and safety protocols, with responsibilities spanning data recording, deviation reporting, and continuous improvement in QC processes.

Qualifications

• Experience in a microbiology lab
• Knowledge of cGMP regulations and SOPs
• Ability to maintain online and offline documentation
• Perform microbiological testing of finished products, RM, and samples
• Operate and validate lab instruments and autoclaves

Responsibilities

• Microbiological testing of finished product, starting materials, stability samples, and R&D samples
• Plan and execute microbiological activities and document results
• Maintain and monitor lab temperatures and incubators
• Prepare media and inoculum; perform microbial assays
• Ensure compliance with safety, PPE usage, and lab permits

Skills

Microbiology

cGMP compliance

Documentation

Lab testing

Equipment calibration

Job description

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

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.