Process SME
- Sweden
- Contract
- Compliance / Quality Assurance
How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!
Our client is currently seeking the skills of a Process SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Technology selection, capacity calculations (process modelling), and preliminary equipment sizing.
- Ensure User Requirement Specification (URSs) are produced and completed technically accurate and appropriate for calibration & qualification execution.
- Lead process risk assessments in order to establish and deliver safe process operations and meet drug product quality requirements.
- Support procurement supplier management efforts to establish qualified suppliers and bid evaluations.
- Work with technology leading equipment suppliers, Design Engineering and Construction firms to successfully deliver an integrated manufacturing operation.
- Review and approve process technical documents from design and equipment supplier firms.
- Understanding and/ or experience with spray drying platforms for inhalation products.
- Technical understanding of basic OSD unit operations.
- A natural communicator with excellent partner engagement & leadership skills.
- Experience in the specification, procurement, installation, start up and commissioning of GMP equipment.
#LI-SC1
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
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
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
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Suraj
I manage this role.