QA Specialist

**A job that makes a difference to our patients' lives? We Offer That.**
**A promising future? We Offer That.**

Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place

Joining our **Biologics QA organization in Ludwigshafen** you will ensure that bulk drug products manufacturing and storage at third party manufacturers (TPM) is performed as per current good manufacturing practices (cGMP), according to Quality Technical Agreements (QTA), local procedures, as per specifications and manufacturing directions provided by AbbVie.

Bring in your expertise and join our team as **Biologics QA Specialist (all genders)**.

**Make an impact and**:

- Lead and ensure cGMP compliant investigations of quality events & manufacturing exceptions.
- Define and follow up on CAPA
- Ensure self-reliant that the Annual Product Review/Product Quality Review (APQR) is prepared according to AbbVie global procedures and QTA
- Organize Quality Management Reviews and other Quality Meetings, implement follows-up actions for Quality System improvements
- Demonstrate profound GMP knowledge in ensuring compliance of TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, comply with cGMP, policies, regulatory approvals, and QTA
- Act a Quality liaison between third party manufacturers and AbbVie Operations in support of commercial operations, new product introductions, and product transfers
- Perform risk assessments on product quality, compliance, and regulatory conformance issues for biologic products; decides upon elevation of events
- Drive product related Change Control Management
- Manage regulatory filing requests in alignment with the QPs
- Be a Project Manager, facilitating a cooperative relationship with other AbbVie Areas/stakeholders including eg Quality, Regulatory, Technical, Supply Chain, along with the TPM sites
- Reports outcome and status to the QP
- Contribute to inspections and audits
- Initiate Continuous Improvement Projects: analyse processes respectively situations and drive to implement improvement actions

**This is how you can make a difference**:

- University /FH degree in natural sciences like chemistry, biology, pharmaceutical sciences or equivalent degree or equivalent experience
- Profound Experience and Knowledge in GMP from production/QA environment/Reg of medicinal drug products
- Minimal 3 years working experience in a GMP environment
- Experience and knowledge in handling of root cause investigations into events and exceptions
- Experience in collaboration with internal/ external and national/ international colleagues
- Experiences in Project Management
- Fluency in German and English

**What we offer**:

- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network

At AbbVie, your individual contributions count - help us achieve more together. Be a part of it and grow with us - go above and beyond