Job Description

Description

The QC Lab Consultant ensures that all products and processes meet the highest quality standards. This role requires a seasoned professional with a robust background in microanalytical and QC chemistry and significant expertise in CSV.

Key Responsibilities:

• Manage daily operations of the QC lab, including scheduling, resource allocation, and workflow optimization.
• Oversee all QC activities related to micro analytical chemistry, including sample analysis, method validation, and data interpretation.
• Ensure that QC testing processes are conducted in accordance with internal SOPs, GMP/GLP guidelines, and regulatory requirements.
• Review and approve QC documentation, including test reports, certificates of analysis, and deviation reports.
• Manage CSV activities to ensure that computer systems and software used in QC operations are validated and compliant with regulatory standards.
• Maintain and update CSV protocols, including validation plans, risk assessments, and documentation.
• Ensure proper execution of validation tests and manage any required system upgrades or changes.

Qualifications:

• Education: Bachelor's degree in Chemistry, Biochemistry, or a related field.
• Experience: Minimum of 10 years of experience in micro analytical chemistry and QC, with at least 10 years of experience in computer system validation (CSV).
• Skills:
• Expertise in micro analytical techniques and QC methodologies.
• Proven experience with CSV, including validation of computerized systems and software in HPLC, Hatch Particle Counters, Autoclaves and pH Meter.
• In-depth knowledge of regulatory requirements and industry standards.
• Proficient in laboratory information management systems (LIMS) and other QC software.

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