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.
Job Tags