Director of Quality

Director of Quality responsible for directing and overseeing chemical, physical, and microbiological testing and auditing of raw materials, in-process, finished products, and stability samples in QC laboratories in compliance with all SOPs, test procedures, and cGMP.

Requirements

• Direct laboratory related investigations
• Prepare protocols and ensure execution of such protocols in a timely manner
• Liaise with AR & D group for transfer of in-house developed and validated methods
• Maintain knowledge of the potential impact of Quality Control activities on activities in other departments
• Provide input to laboratory employees to interpret SOPs and test methods
• Review COAs to ensure compliance with all specifications and approve for laboratory release
• Implement solutions where deficiencies are found
• Provide formal and informal performance feedback to direct and indirect reports
• Provide input on monthly departmental headcount and turnover of tested samples
• Develop and implement systems to improve laboratory GMP compliance and/or productivity
• Review and signoff process validation/cleaning validation protocols/reports
• Must possess skills in analytical testing involving spectrophotometric analytical techniques
• Must be able to understand and explain compendial (USP/BP/EP/JP) procedures
• Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems