Executive Validation (Pharmaceutical)

JOB PURPOSE

• You will be a part of the Project Management Team
• Responsible for the timely Planning, Coordinating and execution of Commissioning, Qualification and Validation (CQV) of New plant and equipment in accordance to cGMP standards.
• Responsible to develop and review CQV plans, Strategies and Schedules in alignment with Project timelines.
• Responsible to develop, maintain, Validation masterplan (VMP), Validation Plan (VP) and Risk assessments in association to the project.

KEY ACCOUNTABILITIES

1. Regulatory Compliance

• Ensure all commissioning, qualification, and validation (CQV) activities comply with regulatory standards such as GMP, FDA, EMA, and ICH guidelines. Maintain audit-ready documentation for all phases of the project.

2. CQV Planning and Execution

• Develop, review, and coordinate commissioning, qualification, and validation activities, ensuring seamless integration with project milestones and objectives.

3. Risk Management

• Conduct risk assessments using tools such as FMEA or HAZOP to identify, assess, and mitigate risks during CQV activities. 
• Ensure that Critical Quality Attributes (CQA) and Critical Process
• Parameters (CPP) are consistently defined, monitored, and maintained throughout the project lifecycle.

4. Validation Planning

• Prepare and review the Validation Master Plan (VMP) and Validation Plan (VP) to outline the scope, strategy, and timelines for CQV activities within the project.

5. Cross-Functional Coordination

• Serve as the primary liaison between engineering, quality assurance, operations, and vendors to facilitate the timely execution of CQV deliverables. Ensure alignment with project timelines, scope and objectives.

6. Project Accountability

• Oversee and ensure CQV activities are completed within the defined scope, schedule, and budget while maintaining high-quality standards.

7. Quality Assurance Collaboration

• Work closely with QA teams to align CQV activities with quality policies and objectives. Support QA in ensuring traceability, compliance, and consistency throughout the project lifecycle.

8. Functional Risk Assessment

• Conduct Functional Risk Assessments to evaluate risks associated with equipment, plant, and other systems that could impact commissioning, qualification, and validation activities.

JOB REQUIREMENT

• Bachelor in Science, Biology, Chemistry / Engineering / Process engineer
• 1 -2 years of Validation experience
• 2 years of Project Management Experience
• CQV in Sterile manufacturing equipment and plant / OSD processes / Facility and Utilities qualification (HVAC, Water System, Clean Steam)
• Experience in Project Management & Commissioning, Qualification, and Validation (CQV)
• Good Communication Skills
• Able to carry out projects independently
• Have good command of leadership and the ability to carry out stakeholder management