Lead and execute validation and qualification activities for manufacturing processes, equipment, and systems in compliance with internal and external standards.
Develop, review, and approve validation protocols, reports, and related documentation to ensure accuracy and regulatory compliance.
Coordinate and oversee the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
Collaborate with cross-functional teams including production, quality assurance, and engineering to ensure seamless validation processes.
Identify process improvements and implement best practices to enhance validation efficiency and effectiveness.
Ensure all validation activities are conducted according to Good Manufacturing Practices (GMP) and relevant regulatory requirements.
Maintain comprehensive records of validation and qualification activities for audit readiness.
Train and mentor junior staff on validation procedures and compliance standards.
Participate in internal and external audits, providing expertise on validation and qualification matters.
Stay updated on industry trends, regulatory changes, and technological advancements related to validation and qualification.
Job Requirements
Bachelor's degree in pharmacy is Must
3 to 5 years of proven experience in validation and qualification within the agricultural, manufacturing, and pharmaceutical industries.
Strong knowledge of GMP, ISO standards, and regulatory requirements relevant to validation and qualification.
Demonstrated experience in developing and executing validation protocols (IQ, OQ, PQ).
Excellent documentation, analytical, and problem-solving skills.
Ability to work effectively in a fast-paced, team-oriented environment.
Strong attention to detail and commitment to quality.
Effective communication and interpersonal skills.
Proficiency in Microsoft Office Suite and validation management software.
Willingness to work on-site and collaborate with cross-functional teams.
