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[¾á¼¾ ¹é½Å] QC Manager
http://careers.jnj.com
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QC Manager
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Janssen Vaccines is in Bio Industry Complex of Incheon Free Economic Zone (SongDo International City), Korea where can see the beautiful sunset of West Sea. Janssen Vaccines belongs to the group of Johnson & Johnson pharmaceutical companies operating under the ¡°Janssen Pharmaceutical Companies of Johnson & Johnson¡± trademark and manufactures high quality pharmaceutical products and innovative vaccines products. Janssen Vaccines has a stellar history of supplying innovative vaccines to the global markets. Today, it is growing as a strategic sterile manufacturing site in ASPAC where has impressive pipeline of new and innovative products for U.S market and global.
1. Æ÷Áö¼Ç: QC Manager
2. °è¿»ç: ¾á¼¾¹é½Å (Janssen Vaccines)
3. ±Ù¹«Áö: ÀÎõ ¼Ûµµ
4. ±Ù¹« ÇüÅÂ: Á¤±ÔÁ÷ (Regular)
5. ä¿ë Àοø: 0¸í
[Summary]
Develops and manages implementation of methods and procedures for inspection, testing and evaluation. Mentors, coaches, trains and develops the quality control staff. Evaluates performance and provides opportunities for growth. Communicates department objectives and metrics and measures results. Participate in planning and implementing changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and. Develops and implements systematic and effective processes to investigate and resolve customer complaints and problems. Manages complaint and returned product process to ensure that prompt and appropriate actions and associated corrections are taken. Manages the development and implementation of metrics and systems to measure and guide improvements to product and system quality and customer satisfaction. Prepares quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities. Prepares and administers budget. Develops cost control initiatives.
[Responsibilities]
1. Ensure robust, efficient, and safe team operations that are compliant with cGMP and regulatory requirement.
2. Develop an effectively functioning Quality control testing team with goals and prioritization aligned with site QC.
3. Lead team staffs, guide career development, conduct performance reviews and establishing training plans. Foster collaborative team environment and high-performance culture.
4. Facilitate/ support market release, new product introductions, team/site/global projects, and continuous improvement activities to reduces costs, improve schedule adherence.
5. Review/ approve documents (raw data, log books, calibrations, SOPs, qualification/ validation protocol & reports, etc)
[Requirements]
• Bachelor¡¯s degree (or equivalent) in Biology, Chemistry, Pharmacy, Microbiology or related scientific discipline with a minimum of 10-12 years of relevant experience (for example, lab testing, executing lab studies, developing and validating test methods in a regulated Quality Lab).
• Understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards, and maintains currency on pharmacopeia compendia
• Leadership skills in coaching, development, planning and problem solving. Focused on team success to meet defined metrics and timelines
• Proficiency with computer systems (Microsoft Office applications, LIMS, Empower, etc.)
• Knowledge in analytical testing method for starting material and biological products
• Knowledge in method transfer, equipment qualification, test method (Chromatography, UV spectrophotometry, Mass spectrophotometry, Bioassay) and computer system validation etc.
• Collaborate with global SMEs for QC method validation and technical transfer activities
• Capability to conduct Out of Specification and Atypical laboratory investigations. Provide impact assessment and drive to closure.
• Capability to provide long-term planning of QC lab capabilities and capacity, including implementation of new technologies into the laboratory
• Knowledge in current FDA regulations, ICH, and applicable foreign regulations
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