For our client, a pharmaceutical company in Leiden, we are looking for a (Sr) Supervisor ELM/Automation
The (Sr.) supervisor will lead the ELM/Automation team (i.e. Lab system Build) of the Business Unit Quality Control - a key role in supporting new products and new technologies by introducing the required automation tools, laboratory systems and equipment. The team consists of approximately 10-14 FTE's (including contractors).
Goal of the function/Primary objective of the Job
Accountable for the personnel in Lab system Build team and their performance & development by performing the 5 conversations. Accountable for effective team performance by setting objectives in line with the business strategy.
Tasks and Responsibilities
- Ensures on-time delivery of validated software, lab system tools and equipment qualification to support new product introduction timelines, meeting cGMP requirements and safety regulations.
- Primary accountability for the planning, organization, day-to-day supervision and execution of daily tasks within the team
- Lead for Manufacturing of the Future activities within Leiden QC, including MFF deep dive assessment.
- Ensures seamless transfer of activities to Life Cycle Management Automation/ELM team (i.e. Lab system Run)
- Deals appropriately with any deviations and notifies impacted Leiden QC teams and management.
- Improves automation and equipment introduction processes to ensure lean and timely introduction while keeping cGMP and safety standards
- Change Agent for introduction of new technologies and tools to allow more efficient work and onboarding new products
- Ensure the team is subject matter expert on automation and ELM processes and has a leading role during the GMP inspections.
- Maintains oversights over the implementation of guidelines, regulations and global standards related to automation and ELM activities.
- Participate in management meetings, joins the quality and DPDS network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM, testing laboratories) to ensure flawless experience. Supports Business Planning and capital forecast processes within Leiden QC
- Master degree in chemistry & biotechnology or equivalent by experience with 5-6 years' experience in the pharmaceutical industry.
- Experience in Quality Control, Method development, validation, automation/ELM, etc.
- Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
- General knowledge of pharmaceutical development & manufacturing
- Organizational planning and problem-solving experience
- Strong leadership & development qualities
- Experience with principles of Process Excellence, Lean manufacturing, etc.
- Good presentation skills
- Excellent knowledge of English
- Experience in managing people (direct report lines, or indirect e.g. projects)
What do we offer
- Contract via Kelly Services of period (40 hours per week)
- Start date: asap
- An international environment where you can learn a lot in challenging projects
When interested please react through the application process with your English resume.
About Kelly Services
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