Executive - Quality Control > Microbiology

3 - 7 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for ensuring microbiological quality assurance and compliance of pharmaceutical products by overseeing and validating microbiology lab activities, documentation, and adherence to cGMP, regulatory guidelines, and company SOPs. Key Responsibilities: - Conduct microbiological testing on raw materials (API & excipients), in-process materials, finished products, and stability samples - Perform routine testing for total microbial count (bacteria/fungi), pathogen detection, and water testing (Purified Water, Water for Injection, Potable Water) - Carry out swab testing for equipment and personnel hygiene and environmental monitoring of manufacturing areas - Prepare and review Standard Operating Procedures (SOPs), specifications, test methods, and analytical reports - Ensure Good Documentation Practice (GDP) and ALCOA+ principles are followed - Handle, calibrate, and qualify instruments like incubators, laminar air flow units, particle counters, autoclaves, pH meters, and conductivity meters - Participate in validations, support production, and handle deviations, out-of-specification results, and corrective actions - Prepare for audits, regulatory compliance, and provide training Qualification Required: - B.Sc. in Microbiology / Biotechnology - M.Sc. in Microbiology / Biotechnology,

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Pelltech Healthcare logo
Pelltech Healthcare

Healthcare Technology

San Francisco

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