Quality Assurance Specialist
: Job Details :

Job Responsibilities:

• The QA Specialist will review and approve batch records, ensuring completeness and compliance with cGMP requirements.
• Conduct reviews of manufacturing and laboratory documentation for accuracy and adherence to quality standards.
• You will support the investigation and resolution of deviations, out-of-specifications (OOS), and customer complaints, including root cause analysis and implementation of corrective actions.
• Assist in internal and external audits, including supplier audits, to verify compliance with regulatory and company standards.
• Monitor compliance with cGMP regulations and quality policies throughout the organization.
• Author, review, and revise Standard Operating Procedures (SOPs) to align with current regulatory and operational requirements.
• Provide assistance during customer and regulatory agency inspections.
• Support vendor audits and maintain supplier-related quality documentation.

Job Requirements

• Bachelor's Degree in Life Sciences, Chemistry, or a related field.
• Minimum of 3+ years of experience in a Quality Assurance role within the pharmaceutical, biotechnology, or related industry.
• Strong understanding of cGMP, regulatory standards (e.g., FDA, ICH), and quality systems.
• Experience with document review, investigations, and quality system processes (e.g., change controls, CAPA).
• Familiarity with FSMS or food safety principles is a plus.