Coordinator, Quality Document Control

The Quality Document Control Coordinator is responsible for BOM review and approval, setting up the system specifications for Finished Goods, Component, Bulk Raw Material, Responsible for Releasing Finished Goods (OTC, Non OTC etc) reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance.  Responsibilities also include assisting during GMP audits interna/external.

 

Primary Duties & Responsibilities:

• BOM review and approval, Set up the system specifications for Finished Goods, Component, Bulk Raw Material, work closely with different department
• Responsible for Releasing Finished Goods (OTC, Non OTC etc)
• Prepare master production records for all OTC products.
• Review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
• Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
• Provide assistance writing OOS.
• File and maintain batch production and control records for OTC product.
• Conduct/review Annual Product Review of OTC products.
• Assist in Internal/External Quality Audits. Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
• Provide GMP Training to other departments as needed
• Researches and prepares data needed for monthly quality metrics reporting
• Assist in any project/task assigned by the Manager.

 

                                                                       

Working Relationships/Key Stakeholders:

• Production, Manufacturing, Planning, NPC, S&OP, Regional Quality

 

 

 

 

Qualifications & Competencies: (List required or desired education; competencies; experiences; soft & hard skills)

 

• Preferable Bachelor's degree (B. A.) from four-year College or university preferably with a Engineering or Science major.
• Two years knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
• Good understanding of 21CFR (Part210-211), ICH guidelines
• Experience with SAP system
• Expert in Excel and PowerPoint presentation.
• Good verbal and written communication skill