We are an ISO 9001-certified company looking for a Quality Assurance Manager (all genders) to develop a GMP-compliant QM system. Ideally, you have in-depth knowledge of GMP guidelines to adapt the existing quality management system accordingly.
Job advertisement – Reference number U20240619
UGA Biopharma was established in 2009 in Hennigsdorf near Berlin, Germany. The company‘s international team of experts specializes in the development of monoclonal cell lines for the manufacture of biologics and biosimilars.
UGA Biopharma supports you all the way, from cell line development and bioprocess drafting down to designing purification and analysis processes. We tailor our services to meet your specific requirements and deliver customized solutions of the highest quality. Alongside our ready-to-use (R2U) cell lines for the expression of biosimilar candidates, our customized First CHOice® feed and media platform for cell cultures provides you with a wide range of options.
Our customers have used products from UGA Biopharma in several clinical studies and obtained relevant market approvals.
We are looking for support for our highly motivated team.
Your tasks in our team:
- Review and analysis of the current quality management system regarding compliance with ISO 9001 standards
- Identify necessary changes to implement a GMP compliant management system
- Close cooperation with various departments to ensure that quality standards are continuously improved and adhered to
- Conducting internal audits to evaluate the effectiveness of the quality management system and identify deviations
- Preparation for external audits and inspections by notified bodies/authorities
- Qualification and validation of analytical processes and systems
- Qualification and monitoring of suppliers in the GMP environment
- Analysis and evaluation of pharmaceutical quality assurance systems
- Qualified support for customers in GMP context
- Development of GMP-compliant documentation (SOPs, risk analyses) in German and English
- Monitoring of the training system
Requirements:
- Bachelor’s/Master’s degree in a scientific field, e.g. biotechnology, pharmacy or chemistry
- Experience in quality assurance, preferably in an environment that includes both ISO 9001 and GMP standards
- Solid understanding of GMP guidelines and ISO 9001:2015
- Experience in the development and implementation of quality management systems
- You are highly proficient in both spoken and written English and German
- You adapt quickly to a changing environment
- A good command of MS office is required
- You communicate proactively and enjoy working with other teams
What do we offer:
- Challenging tasks in collaboration with our specialist departments in the areas of Cell line development, Upstream development, Cell culture media, Downstream development and Analytics
- Opportunities to contribute your own ideas and optimizations
- Good working atmosphere in a motivated team
- Attractive location in Hennigsdorf with direct connection to the Berlin S-Bahn network
- Subsidised ticket for local public transport
- Flexible working hours
- 30 vacation days
- Further training opportunities
- Employee events
- Home office quota
- Bonuses for outstanding performance
- Employee benefits package including company pension plan, company health care, company accident insurance
Additional information:
- Start of employment: as soon as possible
- Duration of employment: permanent position
- Workload: full-time (40 hours)
- Application deadline: August 31, 2024
In UGA Biopharma, you will find an employer that values innovation, committed cooperation between all departments, open and cross-hierarchical communication and a family-friendly personnel policy.
Does this appeal to you? Then we would like to get to know you! Please send us your application by e-mail as a single PDF file including your salary expectations to:
Please also include the reference number and your earliest possible starting date.
