Description

JOB DESCRIPTION

This role is responsible for conducting environmental monitoring activities and quality analyses in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates environmental monitoring data in terms of accuracy and precision against predetermined specifications to ensure facility and product integrity. The position identifies ongoing quality issues related to environmental conditions and takes proactive measures to prevent potential contamination or production problems. It applies various measuring devices, testing equipment, and prescribed methodologies to assess environmental monitoring results based on defined quality criteria. The role audits and monitors environmental conditions and quality control processes against both internal and regulatory standards to uphold compliance. It tests environmental samples from manufacturing areas to verify conformance with quality specifications and regulatory expectations. The position reports environmental monitoring deviations and out-of-specification results to the appropriate quality and production stakeholders. It supports the organization's commitment to maintaining a controlled manufacturing environment for the production of safe and compliant pharmaceutical products.

Essential Functions

Perform environmental monitoring sampling and quality analyses in manufacturing areas in accordance with established specifications and regulatory requirements.
Interpret and evaluate environmental monitoring data for accuracy and precision against predetermined quality and regulatory standards.
Identify ongoing quality issues related to environmental conditions and implement preventive measures to avoid potential contamination events.
Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to assess environmental monitoring results.
Audit and monitor environmental conditions and quality control processes against defined internal and regulatory standards.
Test environmental samples from manufacturing areas to verify compliance with quality specifications and contamination control requirements.
Report environmental monitoring deviations and out-of-specification results to relevant stakeholders in a timely manner.
Contribute to process improvement initiatives by identifying opportunities to enhance environmental monitoring programs and methodologies.
Maintain accurate and complete documentation of all environmental monitoring activities in compliance with GMP and GLP requirements.

Additional Responsibilities

QUALIFICATIONS

Education

B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Executive, QC Environment Monitoring