Validation Manager

Position Summary We are seeking a highly skilled QA Validation Manager to lead validation activities across systems, equipment, and processes. This role ensures compliance with regulatory standards such as cGMP, FDA, and ISO, and plays a critical part in maintaining product quality and operational integrity

Job Description (Validation Manager)

1Responsible for the activities related to Validation / calibration compliance at shop floor and reporting to the HOD-Quality Assurance.

2. Preparation of quality documents like validation master plan, validation protocol and executive summary reports etc.

3. Planning and monitoring for timely completion of all calibration activities for instrument, equipment and any other supporting systems as per the master calibration plan / calendar.

4. Responsible for documentation compliance (PQ) of the new instruments / equipments and execution of equipment validation master plan as per the pre-determined schedules on periodic basis.

5. Updating daily activities, observations and document status to immediate supervisor.

6. Any other activities as assigned by reporting employee

• . 7. Review, retrieval, archival and destruction of all plant related executed documents.

8. Coordination and handling of external audits.

Qualifications

Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field

Minimum 5–14 years of experience in validation and quality assurance, preferably in a regulated industry (Required Pharma experience candidates)

Strong knowledge of cGMP, FDA, EMA, and ICH guidelines

Experience with equipment qualification, process validation, and computerized system validation

Excellent project management and leadership skills

Proficiency in validation lifecycle documentation and risk-based approaches

Preferred Skills

Familiarity with validation software tools and electronic documentation systems

Experience in regulatory audits and CAPA management

Strong analytical and problem-solving abilities

Effective communication and stakeholder management