Senior Executive, QC Environment Monitoring at Amneal India

Sarkhej, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

0.0

Posted On

27 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Environmental Monitoring, Microbiological Testing, Sterility Testing, Aseptic Handling, GMP Compliance, Root Cause Analysis, Endotoxin Testing, Bioburden Testing, ALCOA+ Data Integrity, Media Fill, SOP Preparation, Contamination Control

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities * Perform routine Environmental Monitoring (EM) activities in classified cleanrooms (Grade A, B, C, D areas). * Conduct viable and non-viable monitoring including- Active air sampling, Surface monitoring (contact plates/swabs), Personnel monitoring, Settling plate exposure studies, Particle monitoring support * Perform microbiological testing of Raw Materials, Water Systems (PW/WFI), In-process samples, and Finished Products as per validated methods. * Handling sterility testing activities and ensure proper aseptic handling practices in microbiology laboratory. * Perform microbial limit tests, endotoxin testing support (where applicable), and bioburden testing. * Prepare and review EM and microbiology test records, worksheets, and logbooks in compliance with GMP. * Perform the investigation of EM excursions & Microbiology testing, OOS, OOT, and deviations, and support root cause analysis. * Ensure proper incubation, observation, and interpretation of microbiological test samples. * Maintain microbiology laboratory hygiene, aseptic practices, and contamination control standards. * Ensure calibration, cleaning, and maintenance of microbiology instruments and EM equipment. * Involve in change control review and approval, Deviation, Investigation and root cause investigation. Involve in SOP Review and its implementation and Training. * Support media fill (APS) activities from microbiological monitoring perspective. * Maintain compliance with ALCOA+ data integrity principles in manual and electronic documentation systems. * Ensure timely completion of testing activities to support production and product release timelines. * Assist in preparation and revision of SOPs, protocols, and microbiology-related documentation. * Coordinate with QA, Production, Validation, and Engineering teams for microbiological compliance activities. * Participate in regulatory and customer audits by providing required microbiological data and records. * Support implementation of contamination control practices in sterile manufacturing areas.

Responsibilities

Execute routine environmental monitoring and microbiological testing in classified cleanrooms to ensure sterile manufacturing compliance. Manage investigations for excursions, deviations, and OOS results while maintaining laboratory hygiene and equipment calibration.