Quality Assurance Specialist

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.