Summary:Accountable for leading the daily Quality Operations and Quality Assurance function for the assigned Business Unit (multiproduct manufacturing operation at Building 6 or; the single product manufacturing/packaging operation at Building 41) in the Humacao site pharmaceutical solid dosage. Fully accountable for leading the BU to a decision of product quality and product release activities ensuring that products are manufactured, tested and released in accordance with cGMP's, regulatory requirements, guidelines and product registrations to assure compliance with GMP and applicable site and Technical Operations Policies and Directives. In addition, this position will have dotted responsibility to the laboratories and Quality departments that support on the specific BU. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.Responsibilities: 1. Develops, executes and oversees all the Business Unit (BU) cGMP's processes from receipt, storage and inventory of raw materials to shipment of drug products to assure they are technically sound and comply with Regulatory agencies, BMS standards and regulatory guidelines to support the release of responsible products. 2. Leads the BU to a decision of product quality and product release activities ensuring that products are manufactured, tested and released in accordance with cGMP's, regulatory requirements, guidelines and product registrations. (The product release activities include the contextual review and approval of all batches to assure compliance to registrations, GMP and applicable site and Technical Operations Policies and Directives).3. Leads the review and monitoring of critical BU system performance (water, HVAC, and environmental monitoring) to assure deviations and/or facility performance does not impact on product quality or performance when making release decisions. 4. Ensures robustness and approves investigations and process deviations or incidents where the quality standards of a product or its validation may be questionable ensuring that deviations from procedures and specifications are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence / recurrence of deviations and that no materials are released before the completion of the investigation. 5. Provides guidance and recommendations as to future course (s) of action such as Lessons Learned discussion, training adequacy, and CAPA effectiveness. 6. Represents the Quality Assurance function during FDA, corporate GMP's and customer's compliance audits. Supports the QC/QA efforts during the transference and validations of products.7. Provides management and leadership to Quality Assurance personnel and activities including production oversight, facilities suitability for production activities, record review, site compliance to SOP's and other routine and required Quality Assurance activities supporting daily quality operations and release of product.8. Provides management and leadership to all other Quality departments (laboratory, ATS, Compliance) that provide support to the BU. Alerts site and headquarters management and take appropriate actions in the event of a major operational event or incident, which affects cGMP, BMS policies or regulatory compliance. 9. Defines programs to ensure compliance under regulatory scrutiny and alignment with site operational needs.10. Assures that the Quality Operations personnel supporting the BU are properly trained and follow internal (BMS) and government requirements. 11. Works with Manufacturing Technology Team to establish principals and programs to monitor product performance in accordance with ICHQ 8, 9, and 10 Principals to support product quality operations and release.12. Identifies and communicates any trends our suspect data conditions during release review and identifies product trends that may impact product quality or performance. 13. Monitors routine product stability, complaint, and change control activities to assure product performance continues to support expectations and identifies trends and/or other shifts in data to proactively identify and manage changing product quality profiles and performance. 14. Leads Product Fact Finding meeting and identifies and prepares information and recommendations in support of market action.15. Executes and documents the actions and regulatory communications required as a result of recall or product withdrawal decisions.16. Manages cultural and operational differences in and effective manner.Knowledge/Skill:• BS in Natural Sciences (Chemistry, Pharmacy or Biology) or Engineering • Eight (8) years of experience in Quality Assurance Operations • Strong background in solid dosage manufacturing technologies • Strong ability to develop and apply BMS's operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, and Regulatory areas • Proficient in cGMP's and, FDA and Europe regulations and requirements• Full understanding of the business unit and marketing aspects of pharmaceutical operations in a highly regulated industry • Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management• Innovative and creative and ability to utilize all available resources• PC's and electronic tools working knowledge• Excellent communication skills in both English and Spanish• Very team oriented with excellent interpersonal skills• Able to switch priorities plus manage more than one case at the time• Project Management knowledge capability and ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, research oriented individual - but practical, with an ample sense for innovation• Knowledge in cultural and operational differences
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