Associate, QA Environment Monitoring

Description:

This role supports the quality assurance environmental monitoring function within a pharmaceutical manufacturing environment, contributing to the definition and specification of activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products. The incumbent assists in building and maintaining the infrastructure and systems necessary to ensure the timely delivery of quality products in compliance with applicable regulatory standards. The role participates in auditing, monitoring, and determining the quality of manufacturing processes and environmental conditions against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the QA environmental monitoring framework. The position assists in managing in-process product quality activities and communicates with relevant stakeholders in resolving quality-related issues. It contributes to reporting and troubleshooting manufacturing process deviations and environmental monitoring defects. This role provides structured exposure to pharmaceutical environmental monitoring practices and regulatory compliance requirements.

Essential Functions:

Assist in defining and specifying quality activities, processes, and standards for environmental monitoring in pharmaceutical manufacturing in accordance with cGMP requirements

Support the maintenance of quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products

Participate in auditing and monitoring environmental conditions and manufacturing processes against defined internal and regulatory standards

Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the QA environmental monitoring function

Support in-process quality monitoring activities and assist in managing quality-related interactions with vendors

Contribute to reporting and troubleshooting manufacturing process deviations and environmental monitoring defects

Assist in compiling APQR reports and maintaining quality documentation in compliance with 21 CFR Part 210 and 211

Support change control and deviation management processes under the guidance of senior quality personnel

Participate in complaint and recall assessment activities and contribute to corrective and preventive action implementation

Additional Responsibilities:

Education:

Diploma DBM - Required

Bachelors Degree (BA/BS) B. Sc. - Preferred

Experience:

2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses: