Gmp Documents

vor 1 Woche

Basel, Schweiz gloor&lang AG Vollzeit

GMP Quality Systems Specialist - 6 month fix term contract

Our customer is a big international pharma company with Headquartes in Basel. Own innovative pharmaceutical products are developed in Basel and marketed all over the worlds.

To strengthen the Quality Systems Team, we are looking for a versatile fix term support. 100% job role, Hybrid work offered, 2-3 days on site in Basel required, Swiss contract offered.

**Your responsibility**:

- Local Business Administrator for External Manufacturing GMP IT systems from the change request, upload, review, and approval to the archiving and final disposition
- Work to ensure operational lifecycle management of the GxP systems including change management, obsoletion, archiving and periodic system review processes to ensure e-Compliance and health authority requirements
- Key Administrative Officer for quality systems duties and responsibilities, building and maintaining internal digital tools as well as organizing the logistics for internal and external audits and inspections
- Data provider for weekly, monthly and quarterly KPI’s tracked by quality systems and used for quality management reviews
- Carry out oversight of paper and electronic archiving (inventory, appropriate registration, record traceability, cleaning and final disposition) of GMP documents and records to meet data integrity principles
- Manage the end-to-end life cycle handling of documents and records (electronic and paper basis)

**Your profile**:

- Bachelor’s degree in business administration, economics, computer or natural sciences
- Professional experience in the GxP field
- IT Proficiency in MS Office and good knowledge of e-DMS, SAP and other Data Basis/ repository GxP systems
- Good cooperation and communication skills and strong organizational skills
- Fluent in English, both written and spoken

Your are a flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment

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