Director, Quality – QMR Baxter International Inc. Guayama, PR About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Position Overview Responsible for the direction of all Quality activities for the Guayama, Puerto Rico site. Responsibility includes the development, organization and direction of all Quality activities and programs in the areas of Quality Administration, Quality Assurance, Quality Control and Stability, Vendor Quality Assurance Customer Complaints, FDA and Puerto Rico Regulatory Agency Contacts. It also includes In-Process Manufacturing and Packaging QA, as well as Incoming Materials QA. Responsibility includes the support of site business while complying to budget figures in the most cost effective manner. Responsibilities encompass the above activities and personnel located in Guayama, Puerto Rico. The primary end result is to ensure operations are run within the statutes of the applicable federal law CFR Title 21 while supporting the operations with quality laboratory services, documentation compliance and systems. Essential Duties and Responsibilities: Responsible, either independently or in association with supervised employees, to ensure that all chemistry and manufacturing control sections of NDAs related to Guayama Operations are accurate and written to Baxter standards and are submitted to Regulatory Affairs in a timely manner and followed at all times. Establish, implement and manage the validation program for Guayama Baxter Operation facilities, utilities, equipment and processes based on current industry practices and FDA guidelines. Provide input into the CMC section of the NDA. Comprehend our commitments to the FDA and flag and correct any deviations. Maintain the validation program in the site to comply with FDA requirements. Responsible for the establishment of all specifications for all commercial product as well as the responsibility to assure all products manufactured at the site as well as contracted which are tested at the site conform to Baxter specifications. Ensure suitable specifications are in place to assure products of the highest quality at a reasonable cost. Responsible, in association with supervised employees, for the administration of the customer complaint program, as well as, all customer complaint investigations involving the site. The Director has ultimate responsibility for any FDA interaction, inspection or liaison, resulting from these customer complaints. Ensure our product quality is properly achieved and/or improved based on the customers' input/complaints. Ensure complaints are properly investigated, documented and corrective action taken. Ensure compliance with EQB, EPA, PROSHA and any other applicable laws and regulations, as well as Corporate Baxter EHSS Policies. Ensure that EHS incident investigations are completed on time. Ensure that EHSS Corrective and Preventive Action (CAPA) are implemented timely. Ensure that all reporting employees have the proper EHSS training to conduct their job tasks safely and in compliance with applicable regulations and corporate policies. Assists EHS Department in conducting EHSS Risk Assessment. Ensure timely EHS Gemba Walks and PSEHT monthly inspections. Responsible for Operational Excellence and continuous improvement. Partner with the plant manager on setting clear strategy for the group and the plant. Qualifications: Strong leadership skills and results oriented as well as effective in developing resources. Specific skills are required in computer literacy, communication, interdepartmental relations, process improvements/optimization and cost controls. Education and Experience: BS in science or engineering; advanced degree preferred. Extensive experience (minimum 15 years) supervisor/management in the Healthcare product industry and in the development, implementation and assessment of Quality Assurance and compliance programs for GMP's and FDA regulation guidelines and activities Minimum of five years analytical laboratory management experience with exposure to analytical methods development and testing is preferred. Bilingual - English and Spanish. LI-CV1 Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxter.com and let us know the nature of your request along with your contact information. SDL2017
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