QA Validation and IT Specialist

TATAA is a fast-growing company with two decades of history and is recently backed by a life-sciences investment firm. The company is comprised of a team of scientists providing laboratory services, products, and education/training services across a broad range of nucleic acid analysis technologies including PCR, NGS and proteomics. The company is currently in the process of implementing GLP to support pharma industry with regulated bioanalysis. This position offers an exciting opportunity to be involved early on in setting up TATAA for its next phase of growth.

ARBETSUPPGIFTER
We are looking to expand our QA Team with an experienced QA Validation and IT specialist.

Work tasks
• Managing QA validation activities performed at TATAA covering computerized systems and laboratory equipment
• Authoring, reviewing and approval of IT and equipment validation and qualification procedures, plans, protocols, and reports
• Reviewing and approval of changes, deviations and procedures related to computerized systems and laboratory equipment.
• Securing compliance with internal procedures and external GxP requirements
• Support IT in establishing and maintaining an IT infrastructure qualified for intended use
• Identifying and implementing improvements of the IT system life cycle and validation processes (all systems) to ensure a pragmatic and risk-based validation approach
• Reviewing and assisting in developing standard operating procedures (SOPs) and validation programs
• Supporting IT vendor qualification activities
• In collaboration with head of QA, training, and guidance of site personnel in validation area.


KVALIFIKATIONER
Qualifications
• 5-10 years in a QA validation role within the Life Science industry
• Documented experience with implementing and validating IT systems, as well as supporting and maintaining existing IT systems keeping them in a validated state
• Experience with cloud-based software, internal hosted systems, and qualification of IT infrastructure
• Excellent communication skills in English, both written and spoken

ÖVRIGT
Kindly observe that this is an ongoing recruitment process and that the position might be filled before the closing date of the advertisement.