Validation Team Lead (pharmacy)

Validation Team Lead- Lead and manage validation processes and a team to ensure compliance with industry standards, regulatory requirements, and company policies. Ideal for experienced professionals in quality and validation within manufacturing or pharmaceuticals.

Key Responsibilities

• Lead and manage the Validation Team, including assigning tasks, providing mentorship, and ensuring efficient execution of validation activities.
• Develop and implement validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
• Oversee qualification and validation activities, ensuring alignment with regulatory standards (e.g., GMP, FDA, ISO).
• Coordinate validation project schedules and timelines, ensuring on-time completion.
• Review and approve validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Collaborate with cross-functional teams (R&D, Engineering, Quality Assurance, and Operations) to ensure validation requirements are integrated into project planning.
• Ensure compliance with applicable regulatory guidelines and maintain audit readiness.
• Identify areas for process improvement within the validation program and implement necessary changes.
• Provide training and technical support to team members and other departments regarding validation processes and standards.
• Prepare and present validation status reports to management and regulatory agencies as required.

Qualifications

Education:

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

Experience:

• Minimum 2 years of experience in validation within the pharmaceutical, biotechnology, or manufacturing industry.
• At least 1 year in a leadership or supervisory role.

Skills and Competencies:

• Strong knowledge of validation principles, regulatory guidelines (FDA, EMA, GMP, ISO), and risk management practices.
• Excellent leadership and project management skills.
• Proficient in technical writing and reviewing validation documentation.
• Ability to communicate effectively with cross-functional teams and management.
• Detail-oriented with a strong focus on quality and compliance.

What We Offer

• Competitive salary and benefits package.
• Opportunities for professional growth and career advancement.
• A collaborative and innovative work environment.