QA Manager

Job Requirement

• Create and Establish a scientific approach to the company quality and regulatory system.
• Ensure all GMP, GLP, GCP operations are in compliance

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• Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records.
• Develop strategies for regulatory approval and introduction of new products to market.
• Manage the process from development of regulatory strategies through to approval.
• Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval.
• Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards.
• Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems.
• Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA.
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development.
• Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials.
• Act as company’s representative during regulatory agencies and customer inspections

Qualifications

• BS degree in Chemistry, Life Science or related discipline and a minimum of 10 years of relevant QA and Regulatory experience.
• Familiar to solid dosage pharmaceutical manufacturing process with thorough understanding in GMP, GLP, GCP.
• Expertise in regulatory filing and approval from phase I to phase III. Experience in effectively managing FDA inspections and customer audits

732-429-1858

eayache @ irionline.com

http://www.irionline.com