Siegfried
Quality Systems (Senior) Specialist
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"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality, and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
Your Role:
We are seeking to recruit a Quality Systems (Snr) Specialist to join our Quality (Systems) Department, reporting directly to the Quality Systems & Compliance Manager. This position plays a key role in supporting and enhancing our quality systems by focusing primarily on maintaining electronic quality management tools, ensuring regulatory compliance, and contributing to process improvements. The successful candidate will bring strong analytical skills, a detail-oriented mindset, and the ability to collaborate effectively across teams:
- Supporting the development, control, and continuous improvement of quality principles in alignment with the company's internal quality requirements, and GMP guidelines (such as cGMP, ICH, 21 CFR).
- Managing and maintaining the company’s documentation system to ensure effective control of quality documents such as SOPs, forms, the Site Master File, analytical methods, and batch records.
- Managing and maintaining the company’s electronic systems, ensuring full compliance with Computer System Validation (CSV) requirements.
- Participating in risk assessments related to ongoing site operations, as required.
- Leading and participating in the Site Internal Audit Program.
- Coordinating and managing client and regulatory audits conducted at the site.
- Overseeing the management of the site's archiving system.
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Your Profile:
- A post-secondary qualification in life sciences or a related field; a degree in life sciences is preferred.
- Previous experience in a pharmaceutical quality systems environment is considered an asset.
- Proficient use of MS Office applications, and familiarity with electronic management systems such as TrackWise and LabWare.
- Excellent interpersonal and communication skills both verbally and in writing.
- Strong attention to detail with a proven ability to analyze and troubleshoot problems, identify solutions, and implement effective methods and procedures.
- Highly organized with the ability to handle multiple projects, duties, and assignments simultaneously.
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Your Benefits:
We offer a competitive remuneration and benefits package, including performance-related incentives, health insurance, and opportunities for professional development. The successful candidate will benefit from a collaborative working environment, flexible arrangements where applicable, and career progression within an international organisation.
About Us:
Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
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