Senior QA Associate/QA Lead, Compliance (OSD Pharma Experience Required)

The Senior QA Associate/QA Lead will be responsible for identifying, closing, and implementing corrective actions for cGMP gaps in a Pharma Packaging site. This role involves working closely with Quality Assurance, Operations, and Supply Chain, ensuring compliance with FDA regulations and supporting Serialization and aggregation. The position offers hands-on experience in cGMP operations and a chance to improve site compliance.

Requirements

• Conduct assessment of cGMP Compliance gaps.
• Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA).
• Implement plans for gap closure and follow up on the corrective actions to ensure sustainable cGMP Compliance.
• Interpret, discuss and trends in key Quality metrics data to recommend changes required to sustain Quality and safety of manufactured products.
• Review and release of the batches.
• Participation in qualification of utilities, systems, and equipment on-site.
• Support training programs to ensure competency of personnel engaged in cGMP activities.
• Support all aspects of investigations including out-of-specification and manufacturing investigations.

Benefits

• Hands on experience in pharma packaging
• Opportunity to work in a Pharma Packaging site