QA Specialist

5 months ago

Maidenhead, United Kingdom AbbVie Full time

**Company Description**
**Job Description** QA Specialist**
- Based in either the Marlow or Maidenhead offices with flexible working (3/2 model)
- Reporting to the QA Manager
- Highly competitive salary, Bonus and comprehensive benefits package.

**Role Objectives**

The Commercial Quality Specialist is responsible for **independently** providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.

**Key responsibilities**:

- Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
- Plan, prepare, review and approve quality documentation such as change controls, product reviews and other local requirements.
- Support self inspections, internal, external and MoH audits as directed by the manager.
- Coordinate and investigate quality events such as deviations, non conformances and corresponding action plans including decisions.
- Execute supplier qualification program including performance monitoring for key suppliers.
- Monitor metrics and KPIs to ensure compliance.
- Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

**Qualifications** Qualifications**:

- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, other technical/scientific area or equivalent professional experience.
- Experience in quality assurance, GMP or GDP environment preferred.
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
- 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 as assigned by manager.
- Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.

**Additional Information

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