Document Support Specialist – Production
Permanent / CDI
We are working with a Pharmaceutical company with sites throughout Europe and the World. They are producers of GMP API peptides for customers in Pharma and Biotech fields. They have a portfolio of innovative technologies and work on improving synthesis, quality control, and purification processes.
This position is responsible for daily management of deviations, Change Control, CAPA Plan, Validation, Audit report in accordance with cGMP and SHE rules, related to the production department.
The documentary support reports directly to the Head of Production of the site.
What you’ll do:
This role will principally be there to deliver documentary support for production activities Specific duties will include:
- Ensures the preparation of files for production and ensures their proper maintenance during operations
- Quickly notes any deviations (in the field) from the normal course of operations, and carries out documentary monitoring of deviations over time
- Reviews files after production
- Monitoring of KPIs for CAPA, Deviations and Change Controls
- Make the necessary follow-up for CAPAs, Deviations and Change Controls
- Gives additional training to operators following deviations and CAPA plan
- Participate in equipment validation
- Participate in any additional tasks requested
We are seeking someone with a good knowledge of GMP, Chemistry and Pharmaceutical production. You will have a very good level of attention to detail and be someone who can spot errors and minor issues in documentation. We are seeking experience in a similar role in the Pharmaceutical industry. You will need to have a good level of both English (written and spoken) and French is the site language.
On this occasion, LiCa Scientific is acting as an employment agency.