Senior Quality Assurance Specialist (m/f)

REFERENZNUMMER:

270843/1

IHRE AUFGABEN:

-Responsible for quality oversight of IVDD production and product release, evaluate release testing against requirements, coordinate sample submissions to notified bodies to support product testing and release
-Complete batch record reviews
-Interact with contract manufacturers and act as a quality point of contact for suppliers
-Actively communicate with supply chain, production, marketing/commercial operations concerning product release timelines or status of quality issues
-Serve as subject matter expert (SME) for quality systems (i.e., Deviation Management, Corrective and Preventive Actions (CAPA), Trending, Management Escalation, Product Release, etc. )
-Make quality decisions including but not limited to determination of a quality deviation, product hold, stopping operations, etc. based on the specific circumstances that could affect product quality
-Ensure all manufacturing and packaging are in compliance with Regulatory standards
-Perform root cause analysis and implement CAPAs for quality related concerns
-Identify and implement quality key performance indicators, develop benchmarks, measurements, quantifiable benefits and track progress for areas of responsibility
-Foster a continuous improvement culture by collaborating with other organizations in alignment with Quality strategic objectives
-Review and approve documentation including but not limited to OOSs, deviations, root cause investigations, CAPAs, protocols, reports, procedures, change orders, etc.
-Function as data protection officer

IHRE QUALIFIKATIONEN:

-Bachelor’s degree in chemistry, biology, engineering or other related scientific discipline
-Profound experience in a quality assurance role supporting batch release, non-conforming material reporting, CAPA, vigilance
-Ability to apply knowledge of ISO 13485, IVDD and cGMP standards to the job
-Proficiency in product release and ability to function as a Qualified Person
-Fluent in English and German – spoken and written
-Excellent communication skills
-Ability to function in a team environment

WEITERE QUALIFIKATIONEN:

Quality manager