Description
We are looking for a
GMP Officer (m/f)
Reference: -en
Start: 05/14
Duration: 9 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Establishes and maintains UNIT GMP management system and monitors compliance with internal and external regulations
- Monitors deviation management and drives timely completion of CAPA
- Oversees all GMP activities within the UNIT
- Designs GMP training programs for UNIT staff in coordination with other functions and ensures that sufficient and appropriate training is provided and completed
- Writes and reviews GMP documents (qualification documents, trending reports, SOP, logbooks),
- Maintains UNIT SOP system as appropriate
- Supports GMP audits as appropriate, including organizing and tracking any follow-up action items
- Supports Unit Head in the monitoring of business processes to enable objectives to be met or remedial actions to be taken e.g.
- Timely measurement, reporting, benchmarking and continuous improvement of KPIs
- Actively participates in the PHAD Oral Facilitator Network
Your qualifications
- Science Degree
- Proven track record of working in GMP environment and having quality-related responsibilities
- Formal GMP training
- English and German
Skills:
- Qualification/validation specialist