Quality Management Specialist

Vor 3 Tagen

Leverkusen, Deutschland Proclinical Vollzeit

Proclinical are recruiting a Quality Management Specialist for a pharmaceutical corporation. This role is on a permanent basis and is located in Germany. The client is focused on accelerating and changing the findings, development and production of biologics.

**Responsibilities**:

- Responsible for management and enablement of quality documentation system.
- To offer and support in the execution of quality-linked consistent improvement prospects, you will work in a GMP regulated manufacturing area.
- Recognise prospects for consistent improvement.
- You will assist with the procedures of the quality system such as Deviations, Change Control, Quality management Review Quality Monitoring and Quality KPIs.
- Guarantee that the quality assurance programs and policies are upheld and updated on a routine basis.
- Enable uniform standards for the site and facilitate best practice sharing, thereby adopting the accomplishment of the organisation's objective internationally.
- Evaluate and offer knowledge to Investigations, Root Cause Analyses, Risk Assessments and similar actions of the divisions.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a science or technical connected field and at least 3+ years of experience working in a Quality or regulated organisation or educated to an advanced degree level with at least 2+ years of experience working in quality or a regulated organisation.
- Familiarity with QMS and validated software.
- Able to manage document control system operations.
- Acquaintance with GMP.
- Past involvement working in a pharmaceutical organisation.
- Former acquaintance with EU, regulatory bodies and FDA, TGA, ANVISA or any other.
- Know-how of AMG, AMWHV, EU-GMP (Eudralex Vol. 4) Part I, Part II and Annex 2 as well 21CFR 210 & 211.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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