Main responsibilities:

• Participation in the establishment, qualification and commissioning of the QC laboratory in IFB.

• Implementation of chemical and chemical-physical bioanalytical tests as part of the DS release, incoming material release, in-process controls, clean utility monitoring and cleaning validation of insulin drug substance manufacturing.

• Supporting analytical method transfers and verification/validation activities.

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans

• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans

• Conscientious documentation of all measurement results, raw data and calculations according to cGMP and data integrity requirements.

Participation in the preparation and review of laboratory specifications, methods, procedures, templates, protocols and reports.

• Implementation of device (re-)qualifications under supervision.

• Calibration and maintenance of the assigned equipment or coordination of it, e.g. by external service providers, including the associated documentation.

• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified

• Assist in troubleshooting and investigating analytical issues.

• Receiving, storing, documenting, handling and disposing of reagents and reference standards. Managing reagents, column, reference standards and other testing relates consumables stocks to ensure proper amounts can be used. Manage archives of analytical columns.

• Maintenance of documents, e.g. form sheets, test instructions, SOPs, SOP attachments, Logbooks

Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks

• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately

• Executing assigned CAPAs related to remediation plans, continuous improvements

• Execute other works which is assigned by the line manager.

 

About you

Experience

• Degree in Chemistry/Pharmacy/Biochemistry or Equivalent.

• Associate degree at the minimum. Preferably bachelor or above.

• Minimum of 2 years of pharmaceutical, food or biotechnological industry experience.

• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements

• Experience or wiliness in in-process control analysis of active ingredients is an advantage.

• Experience in carrying out equipment qualification or method validation/verification/transfer is an advantage.

 

Soft Skills:

• Precise, independent and structured way of working

• Proactive Problem-Solving and communication

• Resilience

 

Technical Skills:

• Professional experience in the field of typical instrumental analysis (HPLC, GC, UV,IR, titration, TOC) and wet chemistry analysis.

• Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement

• Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements

• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems

 

 

Languages:

• Familiar with academic English/German and Mandarin across at least two modalities: reading and writing.

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