Job Description

Quality Assurance Department is a support group to the Operational Departments of Manufacturing, Validation, Quality Control, R&D, Warehouse, and Facilities. The Quality Assurance Document Control Manager is responsible for performing technical functions in the QADC group, manages the daily operations of the QADC staff, and interacts with each group to ensure accurate and compliant documents are produced. This role ensures compliance of SOPs, policies, and procedures. This position reports to the Quality Assurance Director.

Responsibilities:

• Develop and implement document control policies and procedures to ensure compliance with industry standards and regulatory requirements.
• Quality check all documents for conformance to plans, EDMS requirements.
• Verify the accuracy and completeness of cGMP documents.
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Maintain all GMP documents in a secure manner at all times.
• Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
• Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
• Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
• Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
• Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
• Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• Ensure adherence to cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the manufacturing process.
• Identify opportunities for process improvements and contribute to the development and implementation of enhancements.
• Organize timelines, schedules, and resources to ensure project milestones are met.
• Conduct risk-based investigations through using problem solving tools.
• Authors, reviews, and approved data/documents such as methods, procedures, policies, and/or protocols.
• Track/Report metrics/KPIs for quality activities to leadership teams as needed.
• Provide training/presentations as needed.
• Provide scheduled, structured training for all users of the EDMS, both internally and externally
• Support regulatory audits and inspections with respect to requested training and documentation needed. Assist in audit preparation.
• Communicate and coordinate with other departments to ensure training and quality compliance.
• Be familiar with the day-to-day activities, personnel, and issues within the facilities.
• Stays current with latest industry trends, tools, and best practices, bringing forth new ideas and challenging status quo.
• Assist the Quality Assurance Management in daily operations, as needed.
• Manage subordinate staff in the day-to-day performance of their jobs.
• Performs other related duties as required and/or assigned.

Experience/Qualification:

• Bachelor’s degree in a relevant scientific discipline or equivalent work experience.
• In-depth knowledge of cGMP and regulatory requirements applicable to the pharmaceutical, biotechnology, or related industries.
• Experience working in FDA regulated environment a plus.
• 8+ years’ experience in a related GMP environment.

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