Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of Engineering functions including validation, qualification and ongoing operation activities of facility, utilities, processes, equipment, instrumentation and to ensure FDA requirements are met.

Essential Duties and Responsibilities:

• Working across functions, to ensuring the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and processes.
• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
• Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation.
• Participate in or lead quality risk analysis.