Quality Assurance Employee (m/f/d)

GULP Information Services GmbH; Ludwigshafen am Rhein; On-site; EUR 55,000 - 85,000; Full time

Job summary

Unknown is seeking a dedicated Quality Assurance Specialist for its Ludwigshafen location to contribute to GMP-compliant batch documentation review, product and protocol review, and system data maintenance in a professional, international environment.

The role requires a Bachelor's in natural sciences with at least 3 years in GMP, knowledge of QA/QC/production documentation, and fluency in German with good English. Proficiency in MS Office and SAP QM/TrackWise is desirable.

Qualifications

• Bachelor's degree in natural sciences required.
• 3+ years of GMP-regulated environment experience required.
• Strong knowledge of GMP guidelines in QA, QC and production.
• Proficient MS Office; familiarity with pharmaceutical quality systems preferred.
• Excellent documentation, communication and teamwork skills.

Responsibilities

• Batch documentation review for GMP-compliant release decisions by QP.
• Product and protocol review of finished medicinal products.
• System and data maintenance in SAP QM and quality systems.
• Certificate management and timely provision of quality certificates.
• Document control and SOP revision participation.

Skills

German language

English language

MS Office

Communication

Teamwork

Education

Bachelor's degree in natural sciences

Tools

SAP QM

TrackWise

LotSmart

OneVault

POMS

Job description

Do you want to make a significant contribution to the safety and efficacy of high-quality pharmaceuticals? For our renowned client in the pharmaceutical industry, we are seeking a dedicated Quality Assurance Specialist / Quality Assurance Employee for their Ludwigshafen location, starting as soon as possible. Look forward to a professional, international environment where precision and teamwork go hand in hand!

Your responsibilities will include:

Batch Documentation Review: Timely and GMP-compliant verification of batch documentation for finished medicinal products, semi-finished products, bulk products, and intermediates to prepare the release decision by the Qualified Person (QP).

Product & Protocol Review: Testing of finished medicinal products and careful review of the associated manufacturing protocols.

System & Data Maintenance: Processing of inspection lots in SAP (QM) and maintenance and research of relevant quality data in systems such as TrackWise, LotSmart, OneVault, POMS, and MS Office.

Certificate Management: Timely creation and provision of quality certificates in the document management system.

Document control & SOPs: Audit-proof archiving of quality documents and active participation in the revision of work instructions (SOPs, forms and templates).

• Completed Bachelor's degree in natural sciences and at least 3 years of professional experience in a GMP-regulated environment (ideally at least 2 years in a comparable QA position).
• Sound knowledge of GMP guidelines in the areas of quality assurance, quality control and production, as well as a very good understanding of documentation requirements.
• Proficient use of MS Office and ideally experience with pharmaceutical quality and ERP systems (e.g. SAP QM, TrackWise, LotSmart, OneVault or POMS).
• An extremely precise, structured, reliable and independent way of working, coupled with high resilience and initiative.
• Fluent German and good English skills, both written and spoken, as well as strong communication and teamwork skills.