Group Analytical Specialist QC (m/f/d) - Method Validation

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is a leading biotech pharmaceutical company that combines the strength of a global organisation with the values of a family business. We specialize in the development and manufacture of high-quality pharmaceuticals derived from human blood plasma and human cell lines.

With over 1,600 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.

Join us in shaping our vision of providing new health solutions advancing human life.

Your main tasks and responsibilities

• Prepare validation documents and other GMP-relevant documents with the support of senior analytical specialists and team leaders
• Develop and validate methods
• Support troubleshooting in the QC laboratories
• Manage sample administration and follow-up of validation-related testing in the QC and R&D laboratories
• Support method transfer and the issue/update of product specifications
• Administer documents required for submission and assist with inspection tasks
• Prepare statistical evaluations of data and reports using Excel

Your expertise and ideal skill set

• University degree (MSc, PhD, or equivalent) in Chemistry or Biosciences
• Work experience in the pharmaceutical industry, especially in the field of method validation (GMP environment), is a plus
• Willingness to travel for business (approx. 5% per year, domestically and internationally)
• Good knowledge of MS Word and MS Excel
• English communication skills (oral and written)
• Strong social and presentation skills
• Strong problem-solving, organizational, and time-management skills. Ability to multitask and a high level of flexibility

Your department - where you make an impact

• We, the Quality Unit, are responsible for the review and approval of pharmaceutical products. This involves ensuring that all products comply with legal requirements and are suitable for their intended use in terms of safety, quality and effectiveness. Defining, improving and checking compliance with the quality system is just as much a part of the job as carrying out laboratory tests and checking all documents.
• The Quality Unit is divided into the departments Quality Assurance, Quality in Operations, Quality Control and Assessment & Release.