Lead the Quality Unit (Investigation) in coordinating scientific/ technical based investigation leading to a defendable disposition recommendation
Administer and coordinate the stability programs for Active Pharmaceutical ingredients (API) and selected Intermediates.
Oversee the annual product review reports that summarize the manufacturing, quality control and other related activities of API produced company
Ensure the facility and products produced by company are validated and manufactured in compliance with corporate and site policies/ procedures, the international guidelines, the FDA cGMP and other similar regulatory standards
Ensure all validation practices are consistent and appropriate site validation procedures are in place
Assist on the validation documents and Facilities & Equipment Change Control review for agreed validation approaches, changes and strategies
Requirements:
Bachelor Degree in Chemistry/Life Science/Chemical Engineering
Knowledge of API manufacturing processes, systems and equipment
Detailed knowledge of ICH and regulatory guidelines associated with stability for APIs, equipment qualification and QA oversight of validation activities
Excellent interpersonal and communication skills, strong leadership skills, strong in technical writing capability, attention to detail, appreciates the value of working to deadlines
