Quality Assurance (Process Validation)

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

PSA Chemicals and Pharmaceuticals Pvt. Ltd.

time outline icon Pithampur, Madhya Pradesh, India

Posted on 19-12-2024

86 Views

1 Vacancy

Description

Develop and execute process validation protocols for new or modified manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure validation activities align with company quality systems and industry regulations
Collaborate with engineering, manufacturing, and regulatory teams to ensure process validation is conducted efficiently and effectively.
Prepare, review, and approve validation protocols, reports, and documentation, ensuring they meet both regulatory and company standards.
Define the scope of validation protocols and ensure that all aspects of the manufacturing process are adequately validated.
Ensure thorough documentation of process changes, validation results, and deviations, following appropriate quality control procedures.
Conduct risk assessments to identify critical process parameters that impact product quality and ensure that controls are in place to monitor and control these variables.
Evaluate potential risks related to the manufacturing process and implement corrective and preventive actions (CAPA) as needed.
Collaborate with other departments to develop process control strategies and ensure consistency across production lines.