Auditor Supplier Quality
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Auditor, Global Product Quality supports auditing and monitoring of the Internal Audit Program, Outsourced GMP Contracted activities, and GMP Suppliers that are utilized in the manufacturing, packaging, labeling, testing and distributing of finished pharmaceutical, medical device, drug/device combination, and investigational medicinal products.
Works with other functional departments across Otsuka Global Affiliates and Subsidiaries to establish and maintain the effectiveness of Quality Systems to support GMP External/Internal Audit programs.
The position requires up to 50% travel; mostly domestic and occasional international travel is expected.
- Support Global Product Quality lead to ensure that all required internal and external audits are planned and scheduled.
- Leads and conducts audits of contractors and suppliers to ensure compliance with Global and Local Otsuka, and applicable regulatory requirements.
- Ensure that audit documentation is accurate, complete, and issued within the required timeframe.
- Review and approve CAPA plans for audit observations.
- Interfaces with Contractors, Suppliers, Tech Operations, Technical Services and Supply Chain, and Clinical Supply Operations to drive Quality improvements that minimize the Costs of Quality, specifically for component, materials or finished product suppliers
- Compiles and reports key performance indicators, metrics and compliance status of Internal Audits and GMP Outsourced Activities to Senior Management.
- Provides reports and trends to the Otsuka Management Representative to help in the preparation of Management Reviews and/or other ad hoc reporting requests.
- Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
- Works collaboratively within Global Product Quality and other functions across Otsuka Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements.
- Assists in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems.
- Participates in Inspection Readiness activities and supports Regulatory Inspections.
- Interface and support project teams to ensure that the goals set by the team as they relate to potential contractors/ suppliers are consistent with global and local quality objectives and relevant governmental requirements.
Travel (approximately 30-50%)
- Bachelor’s degree in Biology, Chemistry, Engineering or other Physical Sciences 2- 5 years of experience in pharmaceutical manufacturing and/or medical device, QA or QC roles
- 1 or more years of Supplier Quality and Internal Auditing experience in the pharmaceutical or medical device industry
- Working knowledge of FDA 21 CFR Parts 820, 211 and 210 quality system requirements
- Ability to handle contractor/supplier audit situations and interactions in a tactful, professional and effective manner
- Ability to manage and prioritize multiple tasks.
- Excellent interpersonal and communication skills
- Ease with electronic environment/ computer skills and Innovation skills.