Quality Control Validation Scientist
Responsibilities:
- Drive analytical method validation/ transfer of laboratory methodologies.
- Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.
- Support troubleshooting of analytical methods.
- Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
- Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.
- Use sound scientific principles and statistical techniques to solve problems and make recommendations.
- May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
- Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
- Minimum of 7 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
- Nice to have the KNEAT Program, not required.
- Experienced in reviewing and approving Life Cycle Validation Documents including:
- Familiar with paperless validation software for life science.
- Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.
- Computer System Validation protocols and reports, including SCADA, MES.
- QC/Micro Laboratory Instrument Qualification and method validation.
- Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.
- Knowledge of analytical methods and operations with strong emphasis in problem-solving.
- Knowledge about analytical method validation.
- Intermediate statistical knowledge and experience with data analysis.
- Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
- Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods.
- Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
- Proficient in Microsoft Office.
- Strategically and business-oriented thinking.
