Your responsibilities
- Leads a matrix team of experts to support product care of 1-3 commercial combination products and is a member of Technical Product Team
- Establish platform documentation (design control documentation) in application lifecycle software
- Acts as a commercial complaint investigation support, evaluates the annual
- Complaint analysis and supports follow up activities, for example, Root Cause
- Investigations, subsequent Corrective Action and Preventative Actions (CAPA) and Changes (Technical Change Management, Transfers, Capacity Expansion)
- Supports or leads technical Changes e.g. Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
- Manage the Product Care Annual Review (PCAR)
- Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertise
- Interpret Pharma Quality System requirements into local operational processes
Your profile
- Bachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and proven track record in the pharmaceutical or related industry
- Demonstrated track record in project management
- Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices
- Self-motivated, pro-active, responsible, result-oriented and an excellent team player
- Experience in working in agile environment and usage of lean tools
- Excellent communication and negotiation skills in German and English (minimum C1 for both languages) with success in building trustful relationships
Your benefits
- A very renowned company
- You will work in an international environment.
About Hays
Our many years of recruitment experience and specialist knowledge of the recruitment market make us a strong partner to have by your side. We maintain intensive relationships with customers across all industries and so can provide specialists with exciting projects and attractive job opportunities. Whether it's working within an international group or with a regional market leader: we look at your interests and experience to locate just the job to suit you. With us, you will find the right working environment – completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Your contact at Hays
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