QA Specialist - Product Testing Review
We are seeking a QA Specialist to join our QA Product Testing Review team. In this role, the candidate will independently review and approve laboratory documentation supporting product release, in-process, and stability testing in accordance with GDP requirements in a GMP-regulated pharmaceutical or biopharmaceutical environment.
Scope and Responsibilities:
- Review and complete laboratory documentation (support stability, product in-process and release testing) .
- Inform about review issues.
- Provide technical support where required.
- Being able to work in accordance with GMP practices, conducting all activities in a compliant manner.
- Provide expertise in selected analytical techniques and thorough understanding and overview of all analytical methods applied for product testing and stability testing.
- Being aware of and comply with Alvotech’s current EHS policies.
- Support deviations and investigations as required.
- Provide support during inspections as required.
- Being independent in assignments. Routinely lead projects and/or supervise small or medium teams of technicians or admin.
- Perform both routine tasks within procedures and processes and non-routine tasks. Take part in large projects.
- Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees.
- Can make adjustments/changes to procedures, processes and projects.
- Can have financial impact through decision making.
- Demonstrate expert knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge.
- Being often an advisory to other less experienced employees.
- Apply good documentation practices when completing records.
Minimum education and experience requirements:
- Education and experience: University degree in a relevant scientific discipline and minimum 1-3 years of relevant experience in pharmaceutical or biopharmaceutical sector.
- Communication skills: Excellent written and verbal communication skills, coordination abilities and good team skills.
- Computer literacy: Proficient in use of a PC and common Microsoft packages such as Word, Excel and PowerPoint.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
Skills Required
- University degree in a relevant scientific discipline
- 1–3 years of relevant experience in the pharmaceutical or biopharmaceutical sector
- Excellent written and verbal communication skills
- Coordination abilities and good team skills
- Proficiency using a PC and common Microsoft packages, including Word, Excel, and PowerPoint
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
