Contract C2C jobs
Title: Quality Control Validation Specialist
Location: Thousand Oaks, California
Job Description:
Analytical method validation/ transfer of laboratory methodologies
Strong technical writing skills
Experienced in reviewing and approving Life Cycle Validation Documents including:
Familiar with paperless validation software for life sciences
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
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.
Qualifications:
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
Education-Experience:
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 sciences
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.
To apply for this job email your details to Shivam.tyagi@anviktek.com