Website HIBA Pharma
Job Details
Job Position – Validation Manager
Company Name – HIBA Pharma
Abu Dhabi.
Site-wide validation activities, including ownership of the Validation Master Plan (VMP) and overseeing various validation processes across the plant.
Requirements:
– Bachelor’s/Master’s degree in Pharmacy, Chemical Engineering, Biotech, or related field
– 8-10 years of experience in pharma/biotech validation, with 5-6 years in a lead/managerial role (experience in aseptic/oncology preferred)
– Proficiency in GMP, Annex 15, GAMP 5, 21 CFR Part 11, and risk-based validation
– Strong documentation skills and ability to lead cross-functional teams
Key Responsibilities:
– Develop and execute the Validation Master Plan (VMP)
– Lead qualification and validation activities for various equipment and facilities
– Define and implement risk-based validation strategies aligned with industry guidelines
– Establish SOPs for validation processes and ensure data integrity standards
– Manage validation of manufacturing processes, cleaning, and computerized systems
– Supervise validation engineers and ensure compliance with regulatory standards
Compliance & Documentation:
– Ensure validation activities meet FDA, EMA, ICH, WHO, and local regulatory requirements
– Maintain comprehensive validation documentation throughout the lifecycle
– Support regulatory submissions with validation data and risk assessments
Email : hr@hibapharma.com
To apply for this job email your details to hr@hibapharma.com