Q.a (Change Control Management) - Central Germany - Contract (1-2 year

A client of mine in Germany is currently looking for a contractor to become a member of staff within the next few weeks. I am hoping this position is of interest to you, and suits your specific skills.

A successful Pharmaceutical company in the central German region is looking to continue expanding by adding a new staff member to their Quality team. The role is an hourly rate contract for 1 -2 years, with the opportunity for extension and a competitive pay rate dependent on candidate qualification.

The role will require candidates to:

- Support the Change Control Process managers, as well as the Incident Management process
- Examination of changes in JIRA control module ECC
- Assisting in the creation/maintenance of divisional specific SOPs
- Organisation, implementation and monitoring of the change control process - with consideration of cGmp/ISO requirements.
- Organization/participation/logging/tracing of the Change Control Board
- Organization, implementation and monitoring of the variance process; processing of variations in JIRA module "deviations" in consideration of cGMP/ISO requirements
- Organization/participation/logging/tracking deviation of Review Boards

Ideal candidates will have:

- A degree in any of the following areas is highly favourable: Pharmaceutical, Chemical, Biotechnology or Biology.
- Professional knowledge of English, as well as other foreign languages.
- Knowledge of national and international requirements (AMG PharmBetrV, cGMP requirements (EU), international guidelines, eg ICH)
- Several years of experience in the pharmaceutical manufacturing/quality assurance
- Knowledge DIN ISO Standards
- Experience in: project management, MS Office, SAP

This role favours hard working, organised and assertive candidates who enjoy working as part of a team. Interviews are available immediately, initial contracts will be 12-24 months with the possibility for further extension, please apply with a recent CV to be considered

If you think you may know someone who is well suited to this role that isn't you self - we do offer a referral fee for a successful suggestion so get in touch.