Development állások Külföldön (minőségbiztosítás)

Own packaging development activities for assigned projects, defining and implementing appropriate primary, secondary, and tertiary packaging solutions from early development through commercialization....

• Lead the planning, execution, and coordination of sterile product development in the formulation lab, focusing on parenteral small molecule and peptide dosage forms.
• Design, review, and recommend changes to scientific protocols and procedures for aseptic processing and sterile manufacturing.

Design Quality Engineer – New Product Development About the Role Department: Quality Assurance Reports to: QMR / Head of Quality Acrostak 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...

• Downstream processing in the field of viral vectors / ATMPs
• Carrying out filtration and chromatography
• Qualification and execution of aseptic manufacturing processes for non-filterable active pharmaceutical ingredients
• Work in cleanrooms up to hygiene zone B

• Coordinate with wet laboratories, contract research organizations (CROs), and external collaborators to facilitate the transfer of imaging data and associated metadata.
• Ensure incoming datasets are delivered according to defined data formats, metadata standards, and project requirements.

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

Lab IT Administrator Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers...

• Provide direct line management for >10 CP Delivery Managers embedded across drug programs and AI/ML model development initiatives
• Build delivery capability through coaching, role clarity, performance management, and career development

Risk-Manager 80 - 100 % (f/m/d) True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the field of ventilators. Hamilton Medical is a leading manufacturer of...

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Planning, writing, reviewing and submitting manuscripts on clinical drug trials in humans for peer-reviewed journals and abstracts for scientific conferences
• Data visualization of data from clinical drug trials
• Supporting preparation of posters and conference presentations

Innovation/Design Control & Project Quality Engineer You can find all of our job offers by clicking here: /. Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics....

CMC Program Lead (Biologics) -Try&Hire (a) As CMC Program Manager, you will play a key role in driving the Chemistry, Manufacturing, and Controls (CMC) strategy and execution for the company's lead biologic program. You will collaborate closely with external Contract Development & Manufacturing...

Scientific oversight and coordination of preclinical and toxicology studies conducted in collaboration with CROs, academic partners, and scientific institutions - covering both GLP-regulated and exploratory/non‑GLP research...

(Associate) Bioanalytical Principal Investigator LBS (100%)Celerion is one of the world's leading bioanalytical contract research companies and has been supporting pharmaceutical and biotech companies around the world for more than 40 years. Celerion offers services for the approval of new drugs -...

Active contribution to international projects in the areas of reimbursement and market access, including coordination, analysis, and substantive input on strategic topics...