Quality Assurance Manager
vor 3 Stunden
Senior Quality Assurance Manager Biotechnology
80 - 100%
Our client is a leading biotechnology scale-up that is experiencing significant growth and is actively seeking to expand their Quality Assurance division with a permanent position in their department. They are at the forefront of scientific innovation and are dedicated to developing groundbreaking solutions that have a positive impact on human health. Joining their team means being part of a mission to maintain the highest standards of quality and regulatory compliance in their products and processes. This is an incredible opportunity to contribute to pioneering advancements in biotechnology while advancing your career in a dynamic and supportive environment. With exciting projects on the horizon and ample room for professional growth, our client offers a unique chance to be part of a progressive company that is shaping the future of the biotech industry.
**Your main tasks**
- Ensure a consistent standard within our organization regarding quality and regulatory requirements.
- Reviews and approves technical documentation components.
- Provides necessary guidance and support to meet design control requirements.
- Ensures readiness for inspections and audits for the systems in our portfolio.
**Your profile**
- A minimum of a bachelor’s or equivalent degree is required. Scientific education in chemistry, pharmacy or biology or related fields is preferred.
- Certifications in ITIL, Agile, and/or Scrum Master methodologies are a plus.
- At least 8 years of diverse experience in regulated industries such as pharmaceutical, medical, biotech, or similar sectors is required.
- Familiarity with relevant standards such as ISO 13485, IEC 62304, IEC 82304, and ISO 14971.
- Experience in creating or reviewing validation protocols, non-conformities, change requests, standard operating procedures (SOPs), validation plans, and reports is mandatory.
- Experience in Quality Assurance and/or Production of pharmaceutical products
- Perfect knowledge of GMP and related guidelines
**Job Type**: 80-100%
**Benefits**:
- Company pension
- Free or subsidised travel
- Free parking
- Parental leave
- Professional development assistance
- Wellness program
- Work from home
Schedule:
- 8 Hour Shift
Supplemental pay types:
- Bonus pay
- Performance bonus
Work Location: In person
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