Officer, QA Validation

Job Overview

The Officer in QA Validation is tasked with ensuring that manufacturing activities and quality assurance procedures comply with Current Good Manufacturing Practices (GMP). This role demands meticulous monitoring, documentation, and validation activities critical to maintaining quality standards within the pharmaceutical manufacturing environment.

Key Responsibilities

• Conduct routine inspections and monitoring of manufacturing areas to maintain compliance with GMP regulations.
• Carry out GMP-related inspections and review quality records from various departments to ensure adherence to standards.
• Maintain high compliance levels with current GMP throughout the organization.
• Ensure accurate and up-to-date documentation practices.
• Review User Requirement Specifications (URS), Design Qualification (DQ), and supplier/vendor documents relevant to qualification efforts.
• Prepare protocols and reports for validation and qualification activities.
• Execute and evaluate qualification, re-qualification, and validation processes for equipment, systems, facilities, and utilities.
• Guarantee that all validations are performed following established procedures.
• Ensure calibration of instruments prior to qualification activities.
• Collaborate with cross-functional teams to coordinate timely completion of qualification and validation projects.
• Develop Standard Operating Procedures (SOPs) for the Quality Assurance Department.
• Assess production floor compliance with quality and safety standards.
• Create, review, and update the Validation Master Plan (VMP).
• Compile and analyze validation documents including preparation, review, execution data, and updates.
• Manage and address any failures encountered during qualification by applying Quality Management System (QMS) tools.
• Lead risk assessment activities concerning equipment, processes, facilities, and systems.
• Perform scheduled viable monitoring in manufacturing clean areas and warehouses.
• Conduct personnel monitoring in compliance with internal quality standards.
• Participate in qualification, requalification, and area qualification activities as necessary.
• Review and approve calibration certificates to ensure accuracy and compliance.

Qualifications

Possession of a Bachelor of Pharmacy (B. Pharmacy) degree is required for this position.