Job Description

Top 5 qualification

1. Investigations root cause analysis or corrective actions
2. Experience computer system validation
3. Annual product review
4. Experience with validation, process, cleaning or equipment validation
5. Any experience around any type of stability program
6. Certified Quality Auditor

• Quality Management System (QMS) – responsible for duties relating to Quality Systems including but not limited to batch record review, document control, change control, annual OTC product review, validation support, stability support, review of quality events, and investigation of market quality events.
• Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Supports additional special projects related to these objectives as required
• Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and cGMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products. A knowledge and understanding of multiple manufacturing processes/formulations, international requirements and bilingual skills are beneficial.
• Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.
• Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. Solutions should be imaginative, thorough, and practicable.

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