QA Executive (Validation)

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Immacule

time outline icon Nalagarh, Himachal Pradesh, India

Posted on 12-03-2024

529 Views

2 Vacancies

Description

Develop and implement validation master plans, protocols, and strategies to ensure compliance with regulatory requirements, industry standards, and company policies.
Collaborate with cross-functional teams to define validation objectives, scope, timelines, and resource requirements for validation projects.
Prepare, review, and approve validation documents, including validation plans, protocols, reports, risk assessments, and deviation investigations, in accordance with regulatory guidelines and company procedures.
Maintain accurate and up-to-date validation documentation, ensuring completeness, traceability, and compliance with established requirements.
Manage equipment qualification and process validation activities, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and process validation studies.
Coordinate validation testing, data collection, analysis, and reporting to demonstrate the effectiveness and reliability of equipment, processes, and manufacturing systems.
Oversee computerized system validation activities, including validation planning, risk assessment, user requirement specification (URS), functional specification (FS), design qualification (DQ), and validation testing.
Ensure compliance with regulatory requirements for electronic records and electronic signatures (21 CFR Part 11) and industry best practices for CSV.
Participate in change control and corrective and preventive action (CAPA) processes related to validation, assessing the impact of proposed changes, and ensuring appropriate validation activities are conducted to support change implementation.
Provide training and guidance to staff on validation principles, procedures, and documentation requirements, promoting a culture of quality and compliance throughout the organization.