QA Senior Specialist

What are we looking for in our QA Senior Specialist?

🔍 Exciting Opportunity in Quality Assurance (QA)!

Are you ready to make an impact in the pharmaceutical industry? We are seeking a dedicated individual to join our team and take on the responsibility of ensuring the quality and compliance of our commercial bulk and finished drug products. As part of this role, you will oversee QA vendor oversight activities, manage change control requests, process product complaints, and much more.

Responsibilities:

• Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements.
• Review batch records and ensure compliance with GMP and registration requirements.
• Lead discussions with contractors on quality-related topics.
• Oversee completion of contractor quality-related activities, including process improvements and quality investigations.
• Participate in self-inspections and external audits of contractor manufacturers and distributors.
• Maintain logs, databases, and files related to product quality activities.

Required Competencies:

• In-depth knowledge of cGMP/GDP regulations.
• Strong analytical and problem-solving skills.
• Ability to build relationships and influence quality decisions.
• Excellent communication and organizational skills.
• Project management expertise.
• Computer proficiency.

Qualifications and Experience:

• Bachelor's degree in a scientific discipline.
• Minimum of 5 years of experience in Quality Assurance in the pharmaceutical industry.
• Extensive experience in chemical, biological, and/or pharmaceutical operations.
• Direct experience interacting with Health Authorities such as FDA and/or EMA.
• Experience in supporting quality at external manufacturing sites.

Don't miss out on this incredible opportunity to contribute to our mission of providing high-quality pharmaceutical products. Apply now and join our dynamic team at Celgene Global Quality Operations!
Apply now!