Quality Assurance Specialist
2 days ago
The cGMP Documentation Compliance Associate for Granules Pharmaceuticals ensures compliance with current Good Manufacturing Practices (cGMP) and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.
Key Responsibilities:
- Manage and maintain company document control and archival systems (hardcopy and electronic) in compliance with internal procedures and policies as well as regulatory requirements.
- Manage the routing, review, approval, distribution, and archival of new and revised controlled documents.
- Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
- Archive and maintain hardcopy and electronic copies of batch records files, audit files, vendor files, product label files, and change history files.
- Control and issuance of labeling components.
- Manage all document control logbooks and spreadsheets.
- Perform the release of finished product batches packaged.
- Provide new hire training on GMP's, Safety, and Pharmacovigilance and maintain the training program documentation.
- Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
- Collaborate with team members to ensure timely deliverables for documentation.
- Ensure all documents are up-to-date with respect to version control and issuance.
- Perform and support maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls, and complaints.
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