About the role
Description:
This role is responsible for conducting in-process and final product quality analyses and laboratory testing in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates laboratory analytical results in terms of accuracy and precision against predetermined specifications to ensure product integrity. The position identifies ongoing quality issues and takes proactive measures to prevent potential production problems, contributing to continuous improvement initiatives. It applies various measuring devices, testing equipment, and prescribed methodologies to accept or reject products based on defined quality criteria. The role audits and monitors laboratory testing processes and outputs against both internal and regulatory standards to uphold compliance. It tests random samples of finished goods to verify conformance with quality specifications and regulatory expectations. The position reports laboratory process deviations and defects in finished goods to the appropriate quality and production stakeholders. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products through rigorous laboratory quality control.
Essential Functions:
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Perform in-process and final product quality analyses and laboratory testing in accordance with established specifications and regulatory requirements
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Interpret and evaluate laboratory analytical results for accuracy and precision against predetermined quality standards
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Identify ongoing quality issues within the laboratory and implement preventive measures to avoid potential production disruptions
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Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to accept or reject products
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Test random samples of finished goods to verify compliance with quality specifications
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Report laboratory process deviations and defects in finished goods to relevant stakeholders in a timely manner
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Support continuous improvement initiatives by suggesting enhancements to laboratory quality processes and testing methodologies
Maintain accurate and complete documentation of all laboratory quality testing activities in compliance with GMP and GLP requirements
Additional Responsibilities:
Education:
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B. Pharm B. Pharm - Required
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M. Pharm M. Pharm - Preferred
Experience:
- 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses:
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