Qualification and Calibration Section Head

EVA Pharma

Key Responsibilities:
Develop and implement the site Qualification Policy, holistic VMP, and qualification/calibration strategies to ensure full cGMP compliance for all facilities, systems, equipment and instruments.

Lead planning and execution of qualification and calibration activities (including FAT/SAT, validation lifecycle, protocols and related documentation), ensuring clear, audit-ready evidence of compliance.

Manage, organize and coach the Qualification and Calibration team, defining workflows, delegating tasks, and building capabilities for both routine and complex activities.

Oversee qualification and calibration documentation, support change controls, deviations, investigations, CAPAs and SOP updates, and ensure risk-based prioritization of critical systems impacting quality, efficacy and data integrity.

Represent qualification and calibration during internal and external audits and regulatory inspections, presenting a clear picture of compliance status and validation efforts.

Ensure robust EHS and safety culture within the team, maintaining compliance with all safety policies and quality systems, and ensuring adherence to cGMP processes, procedures and instructions.

Collaborate cross-functionally to meet project timelines, resolve technical issues related to qualification and calibration, and handle additional duties within the section s scope.