Teamlead Qc Microbiology - Heidelberg, Deutschland - AGC Biologics
Beschreibung
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market.
Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia.
As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.
Summary
AGC Biologics GmbH in Heidelberg is looking for a Teamlead of the QC Microbiology department, which is mainly responsible for the environmental monitoring program, testing of product change over cleaning samples and process support for our GMP production both for early and late phase projects.
Next to the daily people management, the focus in this position is set on teamwork, continuous improvement of processes, coordination and strong communication with external vendors and related departments like QA and Manufacturing.
Do you want to set the future direction for our QC Microbiology department? If you are an experienced leader or want to take the next step in your career, then come and join us ensuring continuous improvement and on time delivery of analytical services for our products.
Responsibilities:
- Oversight of QC Microbiology department
- Leading a Team of 8 employees
- Oversight and coordination of the environmental monitoring program
- Oversight of change over cleaning verification
- Oversight of testing for cell banks and process samples with external vendors
- Oversight of relevant equipment including support of qualification
- Oversight of relevant items in the document management system (DEV, CAPA, CR, SOPs)
- Oversight of hygiene and pest control program
- Support CAPEX process for relevant equipment
- Support laboratory investigations
- Support for Audits and Inspections
- Training of employees
Job Requirements:
- + 3 years of professional experience in a quality position
- Good knowledge of the relevant GMP guidelines, AMWHV and regulations
- Experience in quality control including microbiological test procedures
- Experience with TrackWise Digital or comparable System
- Experience with hygiene and pest control management is a plus
- General knowledge of biotechnology production and relevant QC responsibilities
- Teamoriented and strong quality awareness
- Very good German and English skills
- German work permit is mandatory
- Ready to take responsibility
Our proposal:
- A modern work environment with exciting tasks in a futureoriented industry
- Teamwork with an intercultural and international team with short communication channels across national borders
- A corporate culture characterized by openness and appreciation
- Regular company events, capitalbuilding benefits, company pension plan, job ticket, job bike, employer allowances for lunch, a modern time recording system with a flex working hours account and free fruit and drinks
AGC Biologics GmbH
Czernyring 22
**69115 Heidelberg
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