Harba Solutions Inc.
Job Responsibilities
Conduct quality assurance audits and inspections of manufacturing processes, facilities, and documentation.
Review batch records, SOPs, and quality documentation to ensure compliance with GMP and regulatory standards.
Investigate deviations, non-conformances, and customer complaints; support root cause analysis and CAPA (Corrective and Preventive Action) implementation.
Collaborate with cross-functional teams (Manufacturing, Engineering, Regulatory Affairs) to resolve quality issues and implement improvements.
Support validation activities and maintain QA records in compliance with company and regulatory requirements.
Participate in regulatory inspections and internal audits as needed.
Assist in the development and revision of quality policies, procedures, and training materials.
Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field.
2+ years of QA experience in pharmaceutical manufacturing or biotech.
Strong knowledge of GMP, FDA regulations, and ICH guidelines.
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Conduct quality assurance audits and inspections of manufacturing processes, facilities, and documentation.
Review batch records, SOPs, and quality documentation to ensure compliance with GMP and regulatory standards.
Investigate deviations, non-conformances, and customer complaints; support root cause analysis and CAPA (Corrective and Preventive Action) implementation.
Collaborate with cross-functional teams (Manufacturing, Engineering, Regulatory Affairs) to resolve quality issues and implement improvements.
Support validation activities and maintain QA records in compliance with company and regulatory requirements.
Participate in regulatory inspections and internal audits as needed.
Assist in the development and revision of quality policies, procedures, and training materials.
Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field.
2+ years of QA experience in pharmaceutical manufacturing or biotech.
Strong knowledge of GMP, FDA regulations, and ICH guidelines.
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