Validation Head

Responsible for overseeing all validation and compliance activities within an organization, ensuring that processes, systems, and equipment meet regulatory and quality standards. Key duties include developing validation master plans, managing validation lifecycles, leading a team, collaborating with other departments, and ensuring compliance with regulations like FDA and GMP. This role also involves risk assessment, audit preparation, and continuous improvement of validation processes.

Key responsibilities:-

• Strategy and planning:

  Develop and implement the company's overall validation strategy and master plans.

• Lifecycle management:

  Oversee the entire validation lifecycle for equipment, processes, and systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Team leadership:

  Manage and mentor a team of validation specialists, plan resources, and provide guidance on validation procedures.

• Compliance and documentation:

  Ensure all validation activities comply with industry regulations (e.g., GMP, FDA, EMA) and internal quality standards. This includes creating and approving documentation such as validation plans and reports.

• Cross-functional collaboration:

  Work closely with other departments like Engineering, Quality Assurance, and Production to support both ongoing operations and new projects.

• Risk management:

  Conduct risk assessments and develop mitigation strategies for validation activities.

• Audits and inspections:

  Act as a key point of contact for regulatory audits and inspections, and manage the investigation of any related deviations.

• Process improvement:

  Continuously look for ways to improve validation methodologies and procedures