You perform and coordinate Laboratory Asset Management Program (LAMP) activities.
Calibration Lab
* Supervises operations, including but not limited to protocols, instrument/reference devices' calibration and consumables management.
* Performs calibration of simple laboratory instruments, including but not limited to pipettes and dataloggers, within LAMP internal calibration laboratory.
Administration LAMP
* Works closely with Scheduling & Planning team to manage shipping and reception of assets for external services that can't be performed internally (calibration, maintenance, repair)
* Actively contributes in identifying and implementing Manage to Maintain (M2M) conversions, insourcing maintenance and calibration of devices whenever reasonable.
* Actively contributes to keep updated operational system of records, by adding/amending records to reflect Customer driven changes impacting LAMP / OneSource services' scope.
* Supports Scheduling & Planning team with External Service Providers (ESP) management: Quality and EHS screening, training, escorting within Customer site.
Document Review & Approval
* Reviews and approves documents as part of calibration, maintenance, and repair work
* Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDP gaps in provided documentation.
* Closely collaborate with Equipment Owners (EO) to releases assets after successful completion of calibration, maintenance, and repair work
* Processes Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance.
* Contributes to changes and investigations as a member of cross-functional teams.
Data Management / Administrative Release
* Adds, updates, reviews, and releases positions in the Customer calibration (CCMS) and maintenance (CMMS) databases.
* Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems.
Basic Qualifications
* Bachelor's degree in a Life Sciences, Engineering or Quality/Compliance discipline or equivalent experience preferred.
* Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles in GMP environment. In alternative, equivalent in-lab experience can be considered.
Preferred Characteristics
* GxP hardware and/or software experience preferred.
* Knowledge of cGMP and validation regulations and requirements.
* Knowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements.
* Developed Customer service mindset.
* Be passionate in attention to detail and tech aspects.
* Strong written and verbal communication skills in English (required), German (strongly preferred). Any additional language would be a plus.
* Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.