Execute Compliance area activities related to compliance projects, inspections (external, internal, customers), and regulatory submission documentation.
Responsibilities
- Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the handling of external regulatory inspections and on the resolution of regulatory compliance issues.
- Assists in the development, implementation and continuous improvement of the Internal Audit System and utilizes audits and consultations as a training vehicle to increase awareness of Compliance expectations.
- Monitors and maintains plant compliance with Operations and regulatory/applicable standards requirements.
- Participates in the training of the Internal Audit Team to ensure their knowledge in BOP's, GMP regulations, Operations and Site policies and procedures.
- Audits systems such as: documentation, change control, calibration and preventive maintenance. Also responsible for auditing GLP's and practices, test procedures, and other related documentation.
- Plans and performs internal quality audits of all plant operation, including pre-approval inspection audits and quality system standards, equipment, and all other aspects of the plant’s quality system for compliance with Operations, procedures and applicable regulations, such as FDA cGMP & MHRA regulations/ guidelines, DEA regulations and Puerto Rico Department of Health (Administración de Servicios de Salud Mental y Contra la Adición ASSMCA) as well as serving as escort during Regulatory and
- Assures that quality issues are addressed in conformity with regulatory agencies such as Food and Drug Administration (FDA), the Drugs Enforcement Agency (DEA), Administración de Servicios de Salud Mental y Contra la Adiccion (ASSMCA), Korean FDA, European Agency for the Evaluation of Medicinal Product (EMEA) and the Medicines Healthcare Products Regulatory Agency (MHRA), Mexican Ministry of Health (COFEPRIS), Agencia Nacional de Vigilancia Sanitaria de Brazil (ANVISA) and internal/Operations
- Maintains a corrective action system oriented towards the prompt resolution of quality / regulatory problems identified through internal and external sources of quality data.
- Participates in Operations Compliance, regulatory, third party and client audits as facilitator, back room support. Track and follow up all audit commitments from GMP regulatory agencies, AQR, DEA, ASSMCA, Third Parties and clients and plant Internal Audits. Schedules meetings with senior plant management to discuss audits observations.
- Assists in the implementation of major projects, for achieving an effective and efficient performance that meets Plant and Quality Operations plans for supporting marketing demand. Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required