Experience

Aavis Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Document Control Specialist

  • Aug 2019 - Present

  - Processing GMP controlled documents such as policies, procedures, work instructions, forms, specifications, protocols, reports, and test documentation in the Electronic Document Management System (EDMS/ Veeva Vault) following defined processes/procedures. - Perform review of documents submitted through the change control process for format, completeness, review, and approvals. -Manage and troubleshoot review/approval/obsoletion/retirement workflows within EDMS/QDMS. - Scan, verify, and archive paper records in accordance with record retention requirements per Good Documentation Practices. - Work on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required. - Ensuring the correct and timely implementation of Document Change Controls (DCCs)/Change Requests (CRs). - Ensures that review comments, tracked changes, and impacted documents are addressed. Ensures the integrity of document references. - Notify training coordinators of new and revised IT procedures, ensuring training assignments are updated as required. - Ensures that the periodic review of documentation is correctly scheduled, assigned, and initiated in the QDMS, and is completed in a timely manner. - Identifies deviations from document control procedures. - Provides document control process metrics for management review. - Provides support for internal and regulatory audits/inspections as required. - Supports the administration and uses the Learning Management System (LMS). Show less



UPM Pharmaceuticals, Inc.

• QA Specialist

  • Mar 2018 - Aug 2019

  - Responsible for routing GMP documents like SOP, Work Instruction, User Manual, forms, URS, FRS, DS and protocols on Electronic Quality Management System (EQMS) and Veeva Vault. - Assist in document revision control and change route. - Facilitate and coordinate users with posting effective SOPs and applying training requirements. - Ensuring documents are properly identified, available and meet formatting requirements. - Ensuring documents remain legible, readily identifiable and retrievable from the system. - Assist to track documents from Electronic Document Management System and archival room during internal and external audits of Document Control. - Comply with company’s document control standards, policies and procedures. - Maintain and provide status update for GMP training requirement to users. - Assist in scanning and uploading executed documents on EDMS or Archival Room. - Track in process routing documents and provide weekly status update to the document authors, reviewers and approvers. - Maintain document database (obsolete and current) and assisting users with creating new document or to revise existing effective documents. Show less



Osmotica Pharmaceutical Corp.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Specialist

  • Apr 2017 - Feb 2018

  - Routing validation and IT documents for Draft, Review and Approval cycle on the Company’s Document Management System – Documentum and Sharepoint. - Reviewing document format as per standard approved template requirement. - Ensuring documents are properly identified, available and meet formatting requirements. - Reviewing document details like – header and footer information, pagination, section and step numbering, format editing, watermarking, document title and version number. - Ensuring documents remain legible, readily identifiable and retrievable from the system. - Assist to track documents from Electronic Document Management System and archival room during internal and external audits of Document Control. - Assisting users in document format correction and document review and approval. - Processing document execution requests and providing approved executable copies. - Archiving the executed and approved documents in the document archival control unit. - Store and manage documents in the archival room as per standard operating procedure. - Processing document change request, document revision, review and approval. - Assigning document owner, reviewers and approvers on the system. - Maintain data integrity of the GMP documents as per Good Documentation Practices. Show less