Senior Quality Control Engineer

작업 내용

A Pharmaceutical company is searching for a; Senior QC Lab Equipment Qualification Specialist

Main Responsibilities:

- Ensuring the correct implementation of regulatory requirements, as well as GMP and on-time execution of the qualification of analytical laboratory systems (both standalone equipment and client-server based systems, e.g. HPLC, LC-MS, UV photometer, microplate reader, NIR, IR) for the laboratories of Site Quality Control and the research departments.

- Planning, coordination and implementation of qualification projects within Site Quality Control in the context of laboratory relocations or interdepartmental IT and data integrity projects (e.g. Windows feature release updates, server migrations)

- Creation and review of qualification documents (e.g. User Requirement Specifications (URS), design, installation, functional, and performance qualifications)

- Collaboration with various equipment manufacturers in the context of equipment qualifications

- Provide administrative support to Site Quality Control labs and research departments for troubleshooting, liaison between labs and IT

- Supporting the laboratories of Site Quality Control and the research departments in decommissioning computer-based laboratory systems, including ensuring the readability of GMP-relevant electronic data

- Support in the preparation and monitoring of GMP audits and inspections by authorities

- Preparation and review of SOPs and work instructions in the area of responsibility

- Handling of deviations (Quality Investigations), introduction of preventive and corrective actions (CAPAs), as well as implementation of changes (Change Controls) in the area of responsibility

Qualifications

Your profile

You enjoy working in a team and have strong teamwork and communication skills. You approach challenges in a solution-oriented and systematic manner, are able to solve complex and multi-layered tasks and set priorities correctly. In addition to your assertiveness, you are willing to take responsibility and enjoy making a difference and driving projects forward.

Furthermore, you bring the following qualifications with you:

- Business fluent German and English language skills in written and spoken form

- Successfully completed scientific or technological studies, preferably with a focus on the pharmaceutical, chemical, biotechnological or information technology (IT) sector.

- Several years of professional experience in the GMP area, preferably in the pharmaceutical environment (quality control), as well as experience in the qualification of complex laboratory systems

- Knowledge of regulatory requirements for qualification of computerized systems as well as common data integrity standards in GMP regulated environment (EU GMP Annex 11, 21 CFR Part 11, GAMP 5 etc.)

- Very good IT skills

- Knowledge in administration of Microsoft servers and database systems (e.g. MS SQL) is an advantage

- Experience in administration of analytical laboratory software is desirable (e.g. Empower, Chromeleon, Softmax pro, tiamo, or others)

- Experience in the preparation and support of GMP audits and inspections by authorities is desirable

- Solid knowledge of MS Office