First Shift: 8:00am – 5:00pm and availability off hours to support all shifts.
Assist in the management and coordination of the validation function and aid in the determination of compliance of processes and procedures. Provide leadership and direction as needed to contribute to overall efficiency and effectiveness of the processes.
- Responsible for ensuring compliance of validated systems including equipment, processes, instruments, electronics, software, etc.
- Responsible for writing and executing validation protocols and reports.
- Assure compliance of all products with regulatory and customer requirements. Advise Quality Management and Production Manager of all validation failures and recommendations of corrective action.
- Recognize and react to product and process quality problems, lead problem solving efforts and recommend disposition and corrective action.
- Participate in development and approval of standard operating procedures, validations and other activities to support development of production processes. Assure all procedures associated with drug products maintain compliance to FDA cGMP and other regulatory requirements.
- Maintain validation compliance programs for FDA and other regulatory requirements. Notify Director of Quality and Regulatory Affairs of regulatory compliance requirements and deficiencies.
- Conduct training as required; establish trainer requirements and approve trainers as needed.
- Manage a variety of departmental functions including training and managing projects.
- Participate in customer and regulatory audits as needed.
- Ensuring the stability program is successfully executed and managed while collaborating with the Quality Engineer for execution of the program.
- Perform other duties as assigned.
This position reports directly to the Director of Quality and Regulatory.
Requires bachelor degree in science or math with at least two years of college level chemistry. Three to five years work experience in quality control or assurance in regulated industry such as food, cosmetics or drug manufacture. Knowledge of statistics and basic FDA GMP requirements. Basic knowledge and skills sufficient to manipulate and use Microsoft and other software including work processing, spreadsheets, email, internet access and MRP systems.
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