About the role
Performs the review and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Maintains all documentation pertaining to maintenance, qualification and repair, both originals and electronic records into Customer systems. In constant direct contact with Customer stakeholders, works closely with Customer and workflow specialists’ colleagues in translating maintenance plan into operational scheduling. Works closely with EHS to grant Vendor vetting procedures, as well as Safety processes are duly executed by both internal personnel and External Service Providers (ESP). Convoys ESP across Customer site, acting as her/his responsible person. Also serves as information resource for validation technicians, contractors, and vendors. Contribute with Customer QA and Technical Unit in developing and implementing new specifications. Contribute in change management and deviation tracking processes, including leading or contributing to CAPA. May contribute to developing procedures and/or protocols.
Responsibilities:
Calibration Lab
* Performs calibration of simple laboratory instruments, including but not limited to pipettes and data loggers, within LAMP internal calibration laboratory.
Administration LAMP
* Works closely with Scheduling & Planning team to manage shipping and reception of assets for external services (calibration, maintenance, repair)
* 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 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.