Senior Quality Assurance Professional
3 days ago
Welcome to Allergan, a leader in the pharmaceutical industry. We are seeking a highly skilled Commercial Quality Specialist to join our team. In this role, you will be responsible for providing commercial quality support to ensure compliance with corporate, governmental, and local regulations.
Responsibilities:
- Provide commercial quality support to ensure compliance with corporate, governmental, and local regulations.
- Design and implement effective quality systems, procedures, and processes within cross-functional teams.
- Conduct assessments to determine compliance with processes, procedures, and regulations, identifying potential gaps and implementing improvements.
- Plan, prepare, review, and approve quality documentation such as change controls and product reviews.
- Support internal, external, and MoH audits, leading self-inspections as necessary.
- Coordinate and investigate quality events, including deviations, non-conformances, and corresponding action plans.
- Execute supplier qualification programs, including performance monitoring for key suppliers.
- Monitor metrics and KPIs to ensure compliance.
- Support activities governed by Good Storage and Distribution Practices, including monitoring of controlled temperature and cold chain shipments.
- Support the Management Review process for the affiliate.
Qualifications:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
- 3+ years experience in quality assurance, GMP, or GDP environment preferred.
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault required.
- Full understanding of local GxP requirements, including regulations and standards affecting device, biologics, pharmaceutical products, and cosmetics.
- General knowledge and understanding of AbbVie MD, pharmaceutical, biologic, and cosmetic products and regulations.
- Ability to support projects as a team member or lead as assigned by manager.
- Experience working in both team settings and independently, managing own time effectively.
About Us:
Allergan is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We value employees of the greatest ability without discrimination against any employee or applicant due to race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected group status.
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