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Quality Systems Specialist II
Primary Objectives of this Job
This position is a member of the Quality Systems team which supports the implementation and maintenance of various Quality Systems and to guarantee the quality oversight for validation related activities which includes Data Integrity at site.
• Support the implementation and enhancement of the quality system according to internal and external requirements
• Support the collaboration in enhancement and harmonization of Global qualification/ validation requirements
• Support the site projects on Qualification/ Validation
• Support internal and external inspections
Assessment and Approval of Documents
• Support the implementation of internal and external qualification/ validation requirements
• Compliance with local and global procedures
• Quality approval for qualification/ validation discrepancy
• Support the review of SOP’s
• Review/ approval of study documents
• Review/ approval of specification documents (e.g.User Requirements/ Functional/ Design Specification) on compliance with validation requirements
• Review/ approval of validation documents (e.g. risk assessments, validation plan, validation report)
• Support Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Quality oversight for validation maintenance including Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification)
• Support in the assigned Quality System(s) rollout by ensuring that the following elements of the assigned Quality System(s) is/ are implemented and maintained at the site according to regulatory, and global requirements:
o Change control management, Annual Product Review Management, Quality Improvement Program, Document Management, Investigation Program management, IT Systems Quality
• Support on Supplier Quality Management (Supplier Complaints, Supplier Notification of Change, Quality Agreement, Supplier Monitoring, and SMS Trackwise System)
• Support on Material Management (Specification, Implementation which includes Material Qualification, Impact Assessment, Complaints, and support activities in regulatory, product) Process.
• Support on the review/ approve the Material Qualification protocols, reports, procedures, and other related documents to ensure compliance to internal procedures and regulatory requirement.
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
• Any other duties as assigned by Manager/ Supervisor.
Education and Experience Requirements
• The candidate should have at least have a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline. Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• A minimum experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation, ideally in a multinational company. Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages.
• FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
• Able to logically solve problems in order to find timely solutions.
• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.
Key Skills and Competencies
• Self-study of SOPs
• Approval of study, specification and qualification/ validation documents
• Ability to handle complex qualification/ validation discrepancy
• Assessment of superior internal procedures and external regulations
• Training of relevant topics (incl. creation of training material)
• Good Verbal and written communication.
• Critical thinking and demonstrated problem solving skills.
• Deep knowledge of regulations and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
• Ability to lead / support CAPA investigation
• Ability to provide coaching to others
• Communication skills and organization skills.