QA Validation - Executive

Job Summary

The QA Validation Executive is responsible for reviewing, coordinating, and ensuring compliance of validation activities related to equipment, utilities, computerized systems, processes, and cleaning validation in accordance with GMP, GLP, regulatory requirements, and company quality standards.

Key Responsibilities

Validation Activities

1. Review and approve validation protocols and reports for:

2. Equipment Qualification (IQ, OQ, PQ)

3. Utility Qualification (HVAC, Water Systems, Compressed Air, etc.)

4. Process Validation

5. Cleaning Validation

6. Ensure validation activities are executed according to approved protocols and schedules.

7. Coordinate with Production, Engineering, QC, and Regulatory teams during validation projects.

Quality Assurance Compliance

1. Ensure compliance with GMP, cGMP, WHO, US FDA, EMA, and applicable regulatory guidelines.

2. Participate in risk assessments related to validation activities.

3. Review change controls, deviations, CAPAs, and their impact on validation status.

4. Maintain validation master plans and validation lifecycle documentation.

Documentation & Audits

1. Prepare, review, and maintain validation documentation.

2. Support internal, customer, and regulatory audits.

3. Ensure data integrity and documentation compliance.

4. Track validation commitments and periodic reviews.

Continuous Improvement

1. Identify opportunities for process improvement and validation optimization.

2. Participate in training programs and quality improvement initiatives.

Required Qualifications

1. Bachelor's or Master's degree in Biotechnology, Microbiology, Biochemistry, Life Sciences, Pharmacy, or a related field.

2. 2–5 years of experience in QA Validation within a biotechnology, biopharmaceutical, vaccine, or pharmaceutical manufacturing environment.

Required Skills

1. Strong knowledge of GMP/cGMP regulations.

2. Experience in IQ/OQ/PQ qualification activities.

3. Understanding of process validation and cleaning validation.

4. Knowledge of deviation management, CAPA, and change control systems.

5. Familiarity with regulatory guidelines such as US FDA, EU GMP, WHO, and ICH.

6. Good documentation and report-writing skills.

7. Proficiency in MS Office and quality management systems.

8. Experience with sterile manufacturing or biologics production.

9. Knowledge of data integrity requirements (ALCOA+ principles).

10. Experience supporting regulatory inspections and audits.