Job Description

Job Summary:

The GLP Quality Assurance Auditor is responsible for ensuring that all laboratory activities and processes comply with Good Laboratory Practice (GLP) regulations and company standards. The role involves conducting audits, reviewing documentation, and implementing corrective actions to maintain high-quality standards and regulatory compliance in laboratory operations.

Key Responsibilities:

• Audit Planning and Execution:
• Develop and execute audit plans to assess compliance with GLP regulations and internal quality standards.
• Conduct routine and for-cause audits of laboratory processes, including study protocols, data integrity, and record-keeping practices.
• Identify and document findings, deviations, and non-conformances during audits.
• Documentation and Reporting:
• Prepare detailed audit reports, including observations, conclusions, and recommendations for corrective actions.
• Review and approve laboratory documentation, including Standard Operating Procedures (SOPs), protocols, and study reports.
• Track and follow up on corrective and preventive actions (CAPAs) to ensure timely resolution of identified issues.
• Regulatory Compliance:
• Stay current with GLP regulations, industry standards, and best practices to ensure laboratory operations are compliant.
• Provide guidance and support to laboratory personnel on GLP requirements and quality assurance practices.
• Assist in preparing for regulatory inspections and audits, including pre-audit assessments and documentation reviews.
• Training and Development:
• Conduct training sessions for laboratory staff on GLP principles, quality assurance practices, and audit processes.
• Promote a culture of continuous improvement and compliance within the laboratory.
• Process Improvement:
• Analyze audit results and identify opportunities for process improvements.
• Collaborate with laboratory teams to develop and implement strategies for enhancing quality and compliance.

Qualifications:

• Education: Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Biology, Life Sciences). Advanced degrees or certifications in quality assurance or GLP are a plus.
• Experience: Minimum of 3-5 years of experience in GLP quality assurance or a similar role, with a proven track record of conducting audits and ensuring compliance.
• Knowledge: Thorough understanding of GLP regulations, quality assurance principles, and laboratory operations.
• Skills: Strong analytical skills, attention to detail, and excellent written and verbal communication. Proficiency in using quality management systems and audit tools.
• Certifications: Certification from a recognized quality assurance or auditing body (e.g., ASQ) is preferred.

Application Process:

Interested candidates should submit a resume and cover letter outlining their qualifications and experience relevant to the role.

Job Type: Full-time

Pay: From ?30,000.00 per month

Benefits:

• Health insurance
• Life insurance
• Provident Fund

Education:

• Bachelor's (Preferred)

Experience:

• total work: 3 years (Required)

Work Location: In person