QA Specialist - Product Testing Review

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.

Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.

alvotech.com