AbbVie Regulatory Compliance Officer in Barceloneta, Puerto Rico
Regulatory Compliance Officer
USA, Puerto Rico, Barceloneta
1 additional location
USA, Puerto Rico
Job Responsibilities Include:
Schedules and conducts AbbVie, Ltd. (APL) 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 corporate policies, procedures and applicable regulations, such as FDA cGMP, MHRA, PMDA, regulations/guidelines, DEA regulations and Puerto Rico Department of Health as well as escort during Regulatory and Operations Compliance inspections.
Participate in Operations Compliance, Regulatory, third party and client audits as facilitator, back room support. Track and follow up all audit commitments from c GMP regulatory agencies, AQR, DEA, ASSMCA, Third Party clients and APL Internal Audits. Schedules meetings with senior plant management to discuss audits observations and responses; determines acceptability of audit responses and makes suggestions or recommendations when applicable.
Collects objective evidence and assembles 'proof books' documenting closure of all audits as evidence of implementation, adequacy and effectiveness of corrective actions. Prepares and maintains corporate regulatory metrics and status reports.
Maintains a corrective action system oriented towards the prompt resolution of quality / regulatory problems identified through internal and external sources of quality data.
Gathers the appropriate information and documentation; and submits it to the Traffic Department and/ or the corresponding regulatory agency (such as FDA, Customs, Import/ Export, Department of Agriculture) to get the release of incoming materials in detention/ hold. Collects the necessary information and submit it to clients and third parties (by completing questionnaires, generating certificates, etc.) to achieve site accreditation by foreign regulatory agencies.
Completes and submits the documentation; and makes the corresponding coordination and arrangements to renew APL's permits and licenses (such as ASSMCA, Health Department License, North and South APL Plants Sanitary License, DEA Registrations) and Third Parties Quality Agreements.
Responsible for executing assigned tasks as required by the operational area.
Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.
Knowledge/ Education Required:
Bachelor's Degree in a Science/ Pharmaceutical with License preferred.
Experience in Quality Assurance/Regulatory or compliance. A thorough Knowledge of regulations and standards affecting Pharmaceutical Products (i.e. CFR 210/211, cGMP, Quality Systems, FDA regulations, ICH Q7A).
It requires direct experience with FDA, DEA, and European regulations and experience in government inspection and audit techniques.
Total combined minimum years of experience required- 6 years.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Job Type: Experienced