across sites Ensure alignment with current regulatory expectations, including : EU GMP Annex 1 (2022), Contamination Control... Annex 1 (2022);USP - Microbiological Control and Monitoring of Aseptic Processing Environments;21 CFR Part 211 and FDA...
Strong project engineering fundamentals GMP knowledge is a plus Strong plus (not mandatory): Design control Medical device... regulations Product design in MedTech Injection techniques related to MedTech Risk assessment and control strategy in MedTech...
, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. Drive the...
to take control of your own development and growth. We believe in entrepreneurship and initiative and want to make it easy...
of contact for supporting the CMO in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road... in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results...
and processing of samples, inventory control of reagents and consumables, participation in improvement projects, and execution... and external stakeholders. Experience as a laboratory analyst in the biochemical or medical sector, or within Quality Control...
, Production, or Quality Control. Problem-solving skills and the ability to propose constructive, innovative solutions...
of intralogistics? Job Description Problem statement In modern automated logistics and warehouse environments, plant control... authoritative repository for all characterized pallet types, supporting traceability, version control, and retrieval for future...
of structured problem-solving methodologies (e.g., FMEA) Experience with control systems (PLC, SCADA) Flexibility for shift work...
time, …). Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected...