Role Description The Validation Section Head – Pharma is responsible for leading and overseeing all validation activities within the pharmaceutical facility in Cairo, Egypt. This full-time, on-site role includes planning, executing, and approving validation protocols for equipment, utilities, production processes, cleaning procedures, and computerized systems. The position involves managing a validation team, coordinating cross-functionally with Quality Assurance, Production, Engineering, and Regulatory Affairs, and ensuring that all validation work complies with GMP and relevant international guidelines. Daily tasks include reviewing and updating validation master plans, assessing change controls and deviations, maintaining validation documentation, and supporting internal and external audits. The Validation Section Head also drives continuous improvement in validation practices, provides training and guidance to team members, and supports the introduction of new products and technologies.
Qualifications
- Strong expertise in pharmaceutical validation (equipment, process, cleaning, utilities, and computerized systems) and validation master plan development.
- Solid understanding of GMP, regulatory guidelines (e.g., EMA, FDA, ICH), and quality systems related to validation and qualification.
- Experience leading validation teams, managing projects, and coordinating with cross-functional stakeholders in a pharma manufacturing environment.
- Ability to prepare, review, and approve validation protocols, reports, risk assessments, and related technical documentation with a high level of accuracy.
- Competence in data analysis, problem solving, root cause analysis, and implementation of corrective and preventive actions (CAPA).
- Effective communication skills, with the ability to present validation outcomes and interact confidently with auditors and regulatory representatives.
- Strong organizational and time-management abilities, with attention to detail and a structured approach to planning and prioritization.
- Bachelor’s or Master’s degree in Pharmacy, Chemical Engineering, Biotechnology, or a related scientific discipline.
- Previous experience in a senior validation role within the pharmaceutical industry, ideally in sterile or solid dosage manufacturing.
- Proficiency with standard office and validation-related software tools; familiarity with computerized system validation principles is an advantage.
- Commitment to ethical, non-discriminatory practices and adherence to health, safety, and environmental standards.
