Associate/Director, Quality Control

Essential Duties and Responsibilities

• Manage and achieve pre-defined goals & objectives of department.
• Maintain the laboratories with good housekeeping practices, safety guidelines and ensure compliance with a cGMP environment.
• Insure all testing equipment and applicable software are appropriately qualified and maintained.
• Provide and maintain training to all quality control laboratory personnel.
• Write, revise and approve SOP's, analytical test methods, specifications and technical reports according to the in-house monographs and USP updates.
• Insure all quality standards, methods, specifications & procedures are appropriate and current as per applicable regulations.
• Test, approve or reject all finished products, In-process, stability batches and raw materials according to Company's standard.
• Investigate any test or product failure and write, review and approve reports. Implement and maintain CAPA's and effectiveness monitoring systems in laboratory environment.
• Maintain accurate and complete documentation in compliance with SOPs and cGMP requirements.
• Administer stability testing program
• Manage controlled substances in the laboratory environment.
• Manage and guide for analytical development and validation of the methods and specifications for drug substances and solid oral pharmaceutical dosage forms.
• Recommend and write proposal of all capital projects for the quality control department.
• Drive continuous improvement initiatives to ensure high quality to laboratory execution, on time delivery, and management of cost.
• Other duties related to departmental activities may be assigned by management based on situation and necessity

• Bachelor's Degree in Chemistry or related scientific field and 12+ years related experience in pharmaceutical analysis, Out of that 4+ years' experience at the leadership level in Pharmaceutical analysis - or -
• Doctorate degree in Chemistry or related scientific field and 5+ years related experience in pharmaceutical analysis.
• Ability to read, analyzes, and interprets common scientific and technical journals, financial reports, and legal documents.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to define problems, collects data, establish facts, and draw valid conclusions.
• Working knowledge of instrumentation software used in laboratories.
• Aid in the writing of laboratory practices and procedures.
• Assist in the validation of analytical methods.
• Lead and direct the work of laboratory.
• A wide degree of creativity and latitude is expected.
• Excellent communication skills, including the ability to speak clearly and persuasively in positive or negative situations, listen and gain clarification, respond well to questions, demonstrate effective group presentation skills, and write clearly and informatively.