シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ) Overseas の求人一覧
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Research Analyst【CMIC, Inc.】
Research Analyst – The Research Analyst will perform lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Conduct Bio-analysis validation and sample analysis independently. Conduct Pre-Study with minimal supervision. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records. Provide direction and technical assistance to lesser-skilled team members. Assist with SOP/SWP preparation and other technical related documents including client communications. Perform other routine laboratory duties as deemed necessary. Maintain a safe environment. Requirements: Bachelor’s or foreign degree equivalent in Chemistry, Food Science, Engineering, Food Technology or related field and 1 year of experience in the job offered or experience working in a regulatory laboratory environment. Special skills: 1 year of experience in LC-MS/MS and/or UHPLC-UV; UHPLC-FD; understanding GLP requirements and SOP/SWPs; and utilizing analytical techniques to perform sample analysis. Worksite Location - 2860 Forbs Ave., Hoffman Estates, IL 60192 Any Applicant who is interested in this position may apply by regular mail to: D. Washick CMIC, Inc. 2860 Forbs Ave. Hoffman Estates, IL 60192 続きを見る
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Senior Validation Engineer※CMIC CMO USA
RESPONSIBILITIES OF ROLE Coordinates with Production, Quality, Maintenance, and other personnel as needed to manage projects, capacity increases, and process improvements. Plan, manage, and execute the start-up, commissioning, and validation of new or modified equipment trains to create company cleaning and process validation master plans, and other projects. Writes and executes validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), and Utilities Qualification. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. Coordinates Validation Program activities in compliance with CMIC policy and department, local procedures and regulatory expectations. PRINCIPAL DUTIES OVERVIEW · Develop qualifications and retirement documentation. · Conducts field execution of validation deliverables, resolve any deviations, and author reports. · Assists in maintaining validation process improvement projects · Authors/reviews/updates appropriate SOPs. · Follows pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications. · Works within cross-functional teams and communicate progress effectively to other team members and validation management. · Ensures process and project documentation is accurate and updated. · Maintains safe working environment. · Ensures that all activities are in compliance with cGMP, Health Authority regulations and the CMIC policy. · Supports 3rd party validation activities, where applicable. · Completes assigned validation projects in timely manner. · Maintains and improves job knowledge by remaining current in industry trends, attending educational seminars, reading professional publications and participating in professional organizations. · Performs other special projects and duties as assigned by department management. TECHNICAL KNOWLEDGE · Candidates should have experience in qualification and process validation. · Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ/PQ protocols and final reports. QUALIFICATIONS · Education & Experience · Master’s degree in Pharmaceutical Science or Engineering field required or Bachelor’s degree with at least 7 years of experience. · 3 to 6 years of experience in Pharmaceuticals industries. · Knowledge/Skills · The ability to work successfully in both a team/matrix environment as well as independenly. · The ability to work in a fast paced environment, manage priorities and maintain timelines for multiple projects. ·Ability to utilize Microsoft Word, Excel and Visio, excellent word processing skills · Cognitive Requirements ·Ability to read, write, communicate and handle stress produced by time pressure, customer demands, etc. · Physical Requirements ·Must be able to access all laboratory, manufacturing, and office areas. Must be able to wear the required PPR, for entering laboratory and processing area. Specific vision requires include reading of written documents and use of a computer. Must be able to sit or stand for prolonged periods of time, and occasionally lift up to 25 lbs. with or without assistance. · Licenses & Certifications · N/A Responsibilities and duties are not limited to this Job Description. The employee is expected to follow other instructions and perform other duties requested by the immediate supervisor or company management. The level of involvement may vary based on company need and individual capabilities. Worksite Location - Cranbury, NJ, US office Interested parties, please contact: Name :Khalida Aftab Email: khalida-aftab.ka@cmiccmousa.com 続きを見る
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