Validation Lead
- Germany, Central Germany
- Contract
- Commissioning, Qualification and Validation
This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process.
Responsibilities:
- This hire will be responsible for managing the entire validation element of this project.
- Validation of:
- Equipment
- Facilities
- Utilities
- Clean room
- Ideally German speaking. English speaking is a prerequisite.
- Experience of owning the validation element of a project, defining the strategy, and writing the Validation Master Plan (VMP)
- Experience of writing validation protocols (currently none are written, and they anticipate needing 10-12 for the equipment).
- Experience of writing streamlined validation protocols.
- Experience of executing the protocols.
- Technical experience: Drug Substance – downstream processing; conjugation, purification, molecular, bacterial, peptides. Previously supporting validation activities in this manufacturing environment is essential.
- The ability to communicate to suppliers and internally is essential.
- Ideal experience: Single use technology.
#LI-PH1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Peter
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