A Swiss life biotechnology company is advertising a vacancy for a Production Manager in their office in Lausanne. The organisation focuses on fertility treatment by creating natural, physiological approach to Assisted Reproductive Technologies (ART). This position is an exciting opportunity to work with a leading organisation and provide real expertise in the Medical field.
- Ensuring all products are manufactured according to current design specifications and quality requirements.
- Overseeing production planning, including sourcing, supply chain logistics, and inventory management.
- Reporting KPIs and trends and identifying areas of improvement related to quality, product performance, manufacturing yields, and cost.
- Managing and developing the team of production specialists.
- Maintaining and calibrating production and QC test equipment.
- Developing, implementing, and maintaining quality system procedures related to the manufacturing and supply chain process to ensure clinical grade products.
- Effectively selecting and managing suppliers to support lean manufacturing processes.
- Implementing Change Control and managing manufacturing validation for new products being transitioned into production environment.
- Identifying, recommending, and developing strategies for cost reduction through continuous improvements.
- Ensuring that all equipment is calibrated at the correct time.
- Monitoring inventory status and coordinating with the suppliers as needed to ensure an uninterrupted supply of components.
- Temporarily executing the final assembly, packaging, and sterilisation of the product.
- Participating in the development process to ensure the validation of new products from a manufacturing and quality points of view.
- Supporting the development and the continuous improvement of the quality systems.
- Supporting the QA/RA manager in the execution of internal and external audits (supplier evaluations).
- Managing and/or participating in quality engineering activities, including process validations, CAPAs, complaint investigations, non-conformances, risk analysis, and supplier surveillance.
- Reviewing non-conformities (both internal and external) to determine root causes and corrective and preventive actions.
Skills and Requirements:
- Master's degree or the equivalent in an engineering or life science discipline.
- Manufacturing management experience, including leadership of manufacturing for regulated products, manufacturing engineering, and/or quality engineering activities.
- Supply chain and vendor management experience.
- Experience of Class II a medical device production in a clean room environment.
- Ability to integrate customer demand and business capability projections, which involve manufacturing flexibility, technology migration, quality improvement, and cost management.
- Proven ability to scope, document, resource, load, and manage the manufacturing and production engineering of medical devices in compliance with ISO 13485 requirements.
- Knowledge of electronic and mechanical CAD Software is desired.
- Limited national/international travel required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Vedran Alijagic at +44 203 854 0238 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.