Validation & Qualification Section Head

About the role

As the , you will play a pivotal role in ensuring that our products and processes meet the highest standards of quality and compliance. This position is essential for maintaining the integrity of our operations and ensuring that our pharmaceutical products are safe and effective. You will lead a dedicated team, overseeing validation activities and qualification processes, while collaborating closely with various departments to uphold regulatory requirements. Your expertise will directly contribute to the success of our projects and the overall mission of Acino.

Key facts

What you'll do

• Lead and manage the validation and qualification team, ensuring that all activities align with industry standards and regulatory requirements.
• Develop and implement validation strategies for new and existing products, ensuring compliance with both internal and external guidelines.
• Oversee the qualification of equipment, systems, and processes, ensuring they operate effectively and consistently meet quality standards.
• Collaborate with cross-functional teams, including R&D, production, and quality assurance, to ensure seamless integration of validation processes throughout the product lifecycle.
• Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring accuracy and compliance.
• Conduct risk assessments related to validation and qualification activities, identifying potential issues and implementing corrective actions as necessary.
• Monitor and analyze validation data to identify trends, areas for improvement, and opportunities for optimization in processes.
• Provide training and mentorship to team members, fostering a culture of continuous improvement and professional development within the validation team.
• Stay current with industry trends, regulatory changes, and best practices in validation and qualification, ensuring that Acino remains at the forefront of compliance and quality assurance.
• Participate in audits and inspections, serving as a subject matter expert on validation and qualification processes and addressing any findings or observations.
• Develop and maintain strong relationships with regulatory agencies, ensuring that Acino's validation practices meet or exceed expectations.
• Prepare and present validation and qualification reports to senior management, providing insights and recommendations for strategic decision-making.

Requirements

• Bachelor's degree in a relevant field such as pharmaceutical sciences, engineering, or a related discipline; a master's degree is preferred.
• A minimum of 5 years of experience in validation and qualification within the pharmaceutical or biotechnology industry.
• Strong knowledge of regulatory requirements, including GMP, FDA, and EMA guidelines, as they pertain to validation processes.
• Proven experience in leading teams and managing projects, with excellent organizational and multitasking skills.
• Proficiency in validation methodologies, including process validation, cleaning validation, and equipment qualification.
• Strong analytical skills, with the ability to interpret complex data and make informed decisions.
• Excellent communication skills, both written and verbal, with the ability to convey technical information clearly to diverse audiences.
• Proficient in using validation software and tools, as well as standard office applications.
• Strong problem-solving abilities, with a proactive approach to identifying and addressing challenges.

Nice to have

• Certification in validation or quality assurance, such as ASQ Certified Quality Engineer or equivalent.
• Experience with computer system validation (CSV) and electronic records management.
• Familiarity with Lean Six Sigma methodologies and continuous improvement practices.
• Previous experience in a leadership role within a multinational pharmaceutical company.

Skills & tools

• Strong leadership and team management skills.
• In-depth knowledge of validation and qualification processes.
• Proficient in project management and organizational skills.
• Excellent communication and interpersonal skills.
• Familiarity with regulatory compliance and quality assurance standards.
• Proficient in data analysis and reporting tools.

Practical notes

• The position is based in Cairo, Cairo, and may require occasional travel for audits or training purposes.
• Salary details are competitive and commensurate with experience and qualifications.
• Visa sponsorship may be available for qualified candidates.
• Interested applicants can apply through the Acino career portal at https://acino.bamboohr.com/careers/889.

Join Acino and be part of a team that is dedicated to improving patient outcomes through high-quality pharmaceutical products. Your expertise in validation and qualification will be instrumental in driving our mission forward.