Description
We are looking for a
Sterile Topic Lead - QA Manager (m/f)
Reference: -en
Start: asap
Duration: 9 MM
Place: in Lower Saxony
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Process Simulation which includes the creation of PS site SOP, batch records, protocols and reports, training of operators and inspectors, creation of PS study including all relevant parameters and interventions
- Aseptic Processing which includes the creation of all transfer and storage procedures inside the facility, and in and out of the facility, sterile hold time validation, creation and validation of all cleaning procedures, RABS glove management
- Responsibility for achieving compliance with the requirements including mitigation of determined gaps
- Executing all work required to achieve compliance, including authoring of all relevant documents (protocols, reports, SOPS, etc), and training
- Ensuring optimal alignment/interconnection with Animal Health QMS
- Acting as the subject matter expert for the sterile topic applying advanced theory, technical principles and expert judgment
- Ensuring that the compliance approach and associated documentation is endorsed by global experts
Your qualifications
- BS in Microbiology, Biology, Pharmacy or other related sciences
- Significant experience in human health sterile manufacturing and/or sterile compliance
- Experience in a FDA regulated environment
- Subject matter expert in the sterile topic
- Proven ability to author GMP documentation right first time
- Excellent teamwork skills
- Excellent communication and training skills
- Project experience and ability to work independently
- Ability to operate in a global environment with a high level of diversity and various cultures
- Fluency in German and English
Skills:
- Quality manager