Quality control engineer állások, munkák egészségügy, gyógyszeripar területen

• Bioassay, immunológiai, molekuláris biológiai mérések elvégzése, kiértékelése (sejttenyésztés, SDS-PAGE, Western blot, ELISA, PCR)
• Bioassay vizsgálatok során alkalmazott sejtvonalak fenntartásának és egyéb kapcsolódó tevékenységeknek az elvégzése
• Az elvégzett munka pontos dokumentálása

• Minőségbiztosítás területén dokumentációs tevékenységek végzése, adatok feltöltése, kigyűjtése, elemzése, azok grafikus ábrázolása
• Értékelésekben történő részvétel
• Oktatási rendszer támogatása, tananyagok készítése
• Quality dokumentációk készítésében támogatás, fordítás

Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

Operations Compliance / Quality Specialist (m/w) 100%Career Level: Experienced ProfessionalWorkload: 100%Start and Duration: Immediately for approx. 6 months, with option for extensionWork Location: Kaiseraugst / AGProject ID: A(please always quote when contacting)For an internationally operating...

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Design Quality Engineer – New Product DevelopmentAbout the RoleDepartment: Quality AssuranceReports to: QMR / Head of QualityAcrostak is a global leader in health technology, committed to improving hundreds of thousands of lives worldwide and striving to make the world healthier and more...

Lead Expert Quality Assurance, Deputy Responsible Person 40%Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

Vásárlók kiszolgálása Terméktanácsadás Ügyfélszolgálat magas szintű ellátása (bejövő hívások, e-mailek, chat) Adminisztráció...

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams