Description

You will manage the review and release of manufacturing batch records to ensure strict compliance with documentation standards.

Responsibilities

• Review executed batch records for accuracy, completeness, and adherence to regulatory requirements and cGMPs.
• Prepare Certificate of Conformity (COC), Certificate of Analysis (COA), and related templates.
• Conduct and review nonconformance investigation reports and support supplier corrective actions.
• Perform final disposition of components and conduct periodic reviews of block stock inventory.
• Maintain and archive batch documentation and initiate changes to quality documents under ISO and cGMP standards.

Required Skills

• At least one year of experience in Quality Assurance or Quality Control, ideally in high-volume manufacturing.
• Proficiency with SAP and MS Office.
• Strong mathematical proficiency and analytical skills.
• Experience working within cGMP and ISO regulated environments.
• Ability to follow strict work instructions and quality specifications.
• Strong communication and interpersonal skills.
• High school diploma or equivalent.

Key Skills

Education

Any Graduate