Parenterals Manufacturing Manager Biologics QA

Biologics Drug Product 2 years contract QA elements MS&T

Our customer is a major player in the biopharmaceutical industry offering a wide range of globally established and recognized products. A whole part of the valueadded chain from scale up of R&D processes up to final product launch is led in Switzerland. The new position of a Manager for Sterile Drug Product requires significant experience in manufacturing compounding and filling of sterile drug products in vials prefilled syringes and cartridges.

Your expertise:

• Manage manufacturing or complaint investigations on product impact including root cause analysis CAPA generation and impact assessment
• Support the process capability analysis and Continuous Process Verification of key quality attributes and parameters at the different CMOs
• Provide Impact assessments of change requests
• Support of review of technical documents and data verification activities

You will be Subject matter expert (SME) in sterile manufacturing processes with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes. You have the technical knowledge of sterile manufacturing technology and processing techniques.

Your abilities:

• Experienced as deviation investigator GMP change management and complaint investigations.
• Experienced in the relevant SOPs cGMPs and GLPs guidelines and
• Experienced to work and manage within a regulatory environment.
• Able to work within and lead crossfunctional technical teams across multiple cultures
• Knowledgeable in some statistical analysis capability including use of statistical software platforms

You identify and execute process robustness improvement projects where required. Using this information and knowledge to contribute to comprehensive and accurate annual product reviews as well as performance assessment of CMOs. You will support change management investigation CAPA identification and related activities at the contractor sites.

Your skill profile:

• scientific or engineering degree
• 24 y experience in commercial manufacturing of sterile drug products
• Experience in parenteral compounding and filling
• Involvement in deviations CAPAs and risk assessmets (FMEA)
• Understanding of process engineering analytical and regulatory aspects of sterile drug product manufacturing

Your solutionoriented approach allows you to communicate and negotiate in an effective way. Your English is fluent. The position requires occasional level of travel.