Overview:
My client is one of the top pharmaceutical companies in the world who produces both biopharmaceuticals products and generic medicines. Nearly 215 million people in over 50 countries benefit from one of our clients medicines every day and you can be a part of this production!
Responsibilities:
- Perform paper audits in support of vendor selection and qualification activities.
- Perform on-site audits of vendors in support of vendor approval.
- Draft and manage the lifecycle of Quality Technical Agreements in support of vendor approval.
- Update local SOPs, forms and work instructions as applicable.
- Support general QMS activities and initiatives.
- Support GMP compliance and inspection readiness initiatives.
- Monitor, review and approve Supplier Change Notifications.
- Assist in the continued development and maintenance of the supplier management program.
- Author and/or Support gap assessments of local SOPs to corporate standards.
- Utilize Quality Systems to review and approve change controls, deviations, CAPAs and CAPA Effectiveness checks.
- Assist in the preparation of Site Quality Council.
- 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
- Support regulatory agency filings and inspections.
- Ensure activities are performed/completed using current Good Manufacturing Practices
Qualifications:
- BS/BA or Undergraduate degree in applicable discipline, preferably life science.
- Minimum 5 years of experience in Quality Assurance working with vendor management; including audits and QTAs.
- Advanced knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required
