You manage clinical supply projects, ensuring they are completed on time and within budget while coordinating technical expertise. Your role includes improving processes, developing strategies, and ensuring compliance in packaging operations.
Anforderungen
- •Bachelor's degree in a scientific discipline
- •At least 5 years in pharmaceutical industry
- •At least 3 years in GMP-related disciplines
- •Experience in cGMP manufacturing
- •Experience with cGMP inspections
- •Positive and self-reflective individual
- •Strong communication skills
- •Enjoy working on site
- •High team capability
- •Strong service and customer focus
- •Excellent communication skills in German and English
- •Proficiency in using IT systems
Deine Aufgaben
- •Oversee assigned projects in clinical supply operations.
- •Ensure projects are completed on time and within budget.
- •Coordinate technical experts for project-specific needs.
- •Evaluate process improvements and new technologies.
- •Develop solutions for global clinical supply operations.
- •Support or lead automation and digital transformation projects.
- •Create strategies for asset maintenance and reliability.
- •Enhance packaging development projects based on requirements.
- •Facilitate packaging development between locations.
- •Improve packaging processes to boost productivity.
- •Align activities with strategic goals and compliance.
- •Ensure cGMP compliance in SOPs, Test Plans, and Reports.
- •Drive continuous improvement in processes and documentation.
- •Manage GMP lifecycle using Change Control and Deviation processes.
Original Beschreibung
# Project Manager Packaging Technologies
**Kaiseraugst** | **Full time**
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### The Position
As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development.
## The opportunity:
As Project Manager Packaging Technologies, you’ll work closely together with the technical Experts of the Technology & Validation Team regarding packaging development & CAPEX project management as well as the Engineering-, Compliance- and the Quality Assurance team of the Clinical Supply Packaging Operations (PTDS-O) organization. You’ll play a key role by launching new packaging solutions and by leading key projects and representing the Operations perspective. The key to success in this role is a strong collaboration with stakeholders, service providers and suppliers. The focus is on regional needs for PTDS Kaiseraugst, particularly in the supply of clinical trials with primary and secondary packaging.
* Have full accountability over the assigned / managed projects in clinical supply operations enables a reliable and efficient Clinical Supply Operation and make sure, that projects are finalized in cost and time and coordinates the technical experts of the technic team and decide which expertise is needed for the specific project.
* Evaluation of process improvements, new technology and development of new solutions which are generating the most benefits for the global clinical supply operations organization (in close collaboration with Local SME’s). Support or lead the implementation of new automation and digital transformation projects to enable a digital shop floor.
* Develop a new end of life-, predictive maintenance-, calibration- and reliability strategy for our assets
* Support packaging development improvement projects within clinical packaging operations based on customer, business, regulatory and quality requirements and in line with project timelines and project budget.
* Support the packaging development activities between the two locations South San Francisco and Basel/Kaiseraugst in line with internal and external guidelines and regulations
* Improve packaging processes, increase productivity, reduce lead times and align activities with other related functions to meet strategic goals and responsible for ensuring the cGMP compliant creation of SOP’s, Test Plans & Reports for packaging & warehousing focusing on the technical equipment and processes.
* Continuous improvement of the existing processes and documentation and ensuring the GMP lifecycle by using the Change Control and Deviation process in VEEVA
**Who you are:**
You hold a bachelor degree in a scientific discipline or an equivalent education, with at least 5 years of professional experience in the pharmaceutical/biopharmaceutical industry, including at least 3 years in GMP-related disciplines, as well as experience in cGMP manufacturing of small or large molecules or packaging in the pharmaceutical industry.
* You are a positive, integrative, and self-reflective individual with strong communication skills
* You have experience with cGMP inspections by health authorities
* You are enjoying working on site and are interested in getting to know our production facilities and processes.
* High team capability, solution-oriented approach, strong service and customer focus, excellent communication skills in German and English, and proficiency in using IT systems complete your profile
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**Roche is an Equal Opportunity Employer.**