QA Senior Specialist
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role
As a QA Senior Specialist you will work across different units within the organization. In this role, you will monitor and track changes across the site. Moreover, you will also proactively identify and resolve quality issues to ensure compliance and high productivity.
Your responsibilites
- Developing and reviewing Quality System documentation while ensuring compliance with internal and legal requirements
- Quality oversight over change control and risk management processes in TrackWise system, as well as tracking and monitoring of quality KPI’s
- Ensuring thorough and accurate change controls by working with the team on proper change assessment, task plan definition, required data, completion timing, and effectiveness checks
- Proactive guidance in making improvements to achieve RFT and on-time execution
- Participation in internal and external audits
- Driving continuous improvement to achieve efficiency and productivity by mentoring colleagues and interdisciplinary cooperation between departments and sites
Qualifications:
- Academic degree in Biology, Chemistry, Pharmacy, Biotechnology or other related field
- 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products
- Knowledge of Quality Management Systems
- Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry
- Fluency in spoken and written English
- Ability to multitask and work in a fast-paced entrepreneurial environment
- Capability to think critically, analyze and interpret data independently
- Strong interpersonal and communication skills enabling good cooperation
- Decision-making and problem solving skills
We offer
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more…