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- Management of the Quality Assurance, Quality Systems, Qualified Persons, and Quality Control areas at the site, in line with corporate strategy and within regulatory requirements.
- Maintains, guides, and supports the various elements of quality management including audits, training, SOPs, documentation, change controls, complaints, investigations and CAPAs to ensure ongoing compliance with customer, regulatory and internal requirements.
- Acts as the main point of contact for quality related matters at the PCI Berlin site.
- Acts as main contact person customers and auditors (e.g., of the responsible health authority).
- Leads the Quality department of PCI Berlin (QA, QP & QC).
- Actively promotes best practices for quality management improvement and continuous improvement and problem solving at the
- Leads benchmarking of processes and quality systems.
- Leads project management to ensure effective planning and timely execution of all processes.
- Business or science degree or equivalent qualification.
- Several years of experience in a similar role with demonstrable experience, preferably as a manager
- Knowledge of GMP and GDP regulations.
- Experience in operating ERP systems, ideally JDE (Oracle).
- High level knowledge of packaging equipment, facilities, and processes.
- QMS Experience
- Risk Analysis and Associated Methodology
- Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
- Fluent in business German and English
- Excellent team player with proven leadership experience
Head of Quality - Grossbeeren, Deutschland - PCI Pharma Services
Beschreibung
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main Responsabilities:
Requirements:
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Join us and be part of building the bridge between life changing therapies and patients.