Compliance Officer

5 days ago


Manassas, Virginia, United States Granules Pharmaceuticals Full time

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 issue labeling components.
  • Manage all document control logbooks and spreadsheets.
  • Perform the release of finished product batches packaged.
  • Provide new hire training on GMPs, 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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