For our client, a leading international pharmaceutical company, we are currently looking for a new team member as a:
- Ensure availability and correctness of packaging documentation for sterile and non-sterile medical devices, in compliance with all valid regulations (ISO, MDR, FDA, etc.)
- Check packaging configurations (Bill of material) and packaging validation documentation (package transit qualification, packaging shelf life) in PLM/ERP systems and verify their correctness
- Perform updates/changes (DCR/DCO) for non-conforming packaging documents and Bill of Materials in the systems (Agile/SAP/Windchill)
- Support Shelf Life activities and create/update shelf life specific documentation for Eu and US
Position Duties and Responsabilities
- Review and update technical reports, procedures, policies and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements and current technology.
- Plan, schedule and track project timelines using appropriate tools.
- Establishes and tracks critical milestones, timelines and contingency plans
- Follows up throughout project process to ensure project goals are achieved
- Seeks out continuous improvement opportunities and oversees timely implementation of efficient manufacturing practices.
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for all packaging related change requests through Agile PLM software.
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) for shelf life related change requests through Agile PLM software.
- Technical understanding (drawings, processes, packaging specifications and materials, validation standards (ISO11607, ISTA3A, ASTM standards for testing…), etc.)
- Initiate, route, verify and handle all the administrative paperwork and formalities in coordination with multiple departments stakeholder contacts.
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Professional Experience Requirements
- at least 4 years' work experience in an adequate position and regulated industry preferred
- Experience in an Medical Device regulated environment, package qualification or quality eng. department a plus
- Proven exceptional written and oral presentation skills
- Bachelor's degree in engineering or related discipline, or equivalent and extensive related project experience.
- Certificates in Program/Project Management will enhance candidacy but are not a requirement
- Strong knowledge and skills in MS Office
- Knowledge and skills in PLM system, ex. Windchill, Agile, Adaptive, SAP will enhance candidacy
- Must be highly organized, creative, articulate and analytical
- Strong interpersonal and diplomatic skills
- Ability to multi-task independently with minimal supervision
- English spoken and written
Start Date: asap
Duration: 1 year
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).