Manager GMP Training Oversight

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Manager GMP Training Oversight position is filled by a professional who possesses the advanced compliance and Regulatory knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations for commercial and clinical biopharmaceutical manufacturing. The incumbent works to assure the quality, accuracy, and integrity of data in manufacturing operations, and regulatory submissions and to assure that effective and appropriate Quality Management Systems are in place and followed. The incumbent applies experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude.

The position involves advanced knowledge of the Quality Management System (QMS) and its implementation in relation to the ICH Q5 (cell bank), ICH Q7, ICH Q9, ICH Q10, 21 CFR 11/211, including phased GMP approach and Annex 11 requirements at the site.

Essential Responsibilities

• Subject matter expert in training execution and compliance in pharmaceutical environments
• Implementation/Oversight of training documentation to ensure compliance of training with assigned responsibilities
• Review training documentation to ensure employee comprehension of assigned responsibilities
• Assess training management system and monitor training record data for continuous improvement
• Assist in the development, management, and improvement of the Quality Management System (QMS) to ensure compliance with applicable regulations and company procedures, in support of GMP commercial and clinical manufacturing, and bioanalysis activities.
• Author and/or Support gap assessments of local SOPs to corporate standards.
• Update local SOPs, forms and work instructions as applicable.
• Support general QMS activities and initiatives.
• Support GMP compliance and inspection readiness initiatives.
• Support regulatory agency filings and inspections.
• Ensure activities are performed/completed using current Good Manufacturing Practices
• Utilize Quality Systems to review and approve risk assessments, change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
• Develop and/or deliver training programs, and administration as required, e.g., GMP, data integrity, good documentation practices, and inspection readiness.
• Lead compliance improvement projects as applicable.

Additional Compliance Responsibilities:

• Use of Microsoft Word, Excel, and PowerPoint to support compliance team activities.
• Serve as Quality resource, representing QA on teams in support of assignments.
• Support cross functional department customers in a manner which is clear in approach, communication and action.
• Assist in the planning and execution of Internal Audits.

Your experience and qualifications

Qualifications

• BS/BA or Undergraduate degree in applicable discipline, preferably life science.
• Minimum 5 years of experience in Quality Assurance
• Advanced knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required

Enjoy a more rewarding choice

Make a difference with Teva Pharmaceuticals

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