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Senior QA Manager for Parenteral Products Manufacturing
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 151
Update day: 22-02-2024
Category: Quality Assurance / Quality Control
Industry: Staffing Recruiting
Position: Mid-Senior level
Job type: Full-time
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Job content
Job Title: Local Quality OwnerJob Function: QualityJob Sub functione: Quality (Generalist)Duration: 18/04/2023 to 31/12/2023 (Likely to be extended)FTE/volume in %: 100Position SummaryWe are seeking a Local Quality Owner to oversee quality assurance (QA) for selected parenteral products manufactured at our clients site. As the Local Quality Owner, you will be responsible for ensuring the quality oversight of all relevant activities in sterile fill and finish, assembly, and packaging of the respective combination products (if applicable). The successful candidate will play a key role in ensuring that our products meet regulatory guidelines and quality standards.Main Responsibilities- Ensure on-time release of parenteral products, including intermediate and finished products
- Proactively mitigate risks to ensure quality standards are met
- Lead investigations for major non-conformance’s (deviations)
- Review and approve non-conformances (deviations) records and change control requests
- Review and approve GMP critical SAP master data, such as bill of materials, manufacturing instructions, etc.
- Review and approve work instructions and standard operating procedures
- Issue and review Quality Agreements
- Provide support for projects and customers (production, logistics, engineering, etc.) in terms of GMP compliance
- Review Product Quality Reviews
- Master’s degree in a technical or science discipline
- Five to ten years of experience in a GMP regulated Pharma production environment or five years of experience in a relevant quality role
- Strong background in regulatory guidelines preferred
- Knowledge in aseptic processing preferred
- Experience as a team or project lead preferred
- Advanced communication skills in German and English (oral and written)
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Deadline: 07-04-2024
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