Project Description:
- Writing and reviewing cleaning verification, (re)validation and annual assessment protocols and reports, and ensuring these comply with our global cleaning policies, procedures and guidelines, and external regulatory requirements;
- Planning and coordinating the execution of (annual) cleaning validation activities together with operations and scheduling;
- Writing and maintaining Master Cleaning batch records;
- Coordinate and author cleaning related events (deviations), including performing impact assessment, root cause analysis, and CAPA development/implementation;
- Organizing, performing and reporting annual / baseline visual inspections of product contact equipment;
- Providing technical and hands-on support towards Operations with regard to cleaning processes and cleaning validation activities;
- Supporting cleaning development, e.g. soil characterization, and swab recovery testing;
- Driving improvements in cleaning (validation) processes and leading efforts in completing the intended improvements;
- Depending on department needs and your experience, the role may include the above responsibilities for sterilization (validation) for autoclave or hot air sterilizers
Requirements:
- Knowledge of regulatory cleaning validation expectations, sterilization process (validation)
- Proficient in cGMPs and EHS as it applies to the pharmaceutical industry
Details:
- Capacity: fulltime (min. 0,8 FTE)
- Timeline: 6 months +
- Start: August 2023
