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Job Description
Job Summary
Optum is seeking a highly skilled Documentation Control and Training Lead to join our team in Dublin or Letterkenny. As a key member of our quality assurance team, you will be responsible for developing and maintaining comprehensive training programs focused on quality assurance and regulatory compliance.
Key Responsibilities
- Develop and maintain a Documentation Control process to ensure alignment with principles for Good Documentation Practice (GDP)
- Manage the intake, handling, and storage of documentation
- Ensure all documentation meets formal requirements and required standards
- Review and update documents as necessary
- Track and manage versions of documents
- Retrieve files as needed by company staff
- Securely backup and store documents to ensure all documentation is discoverable and accessible
- Ensure proper organization and categorization of documents
- Coordinate with project teams to ensure all documents are accounted for and in the appropriate location
- Monitor regulatory activity to maintain compliance with records and document management laws
- Support deviations and investigations related to Documentation control
- Support internal audits and external inspections as required
Training Responsibilities
- Develop and maintain training program and related materials to upskill employees on pharmaceutical quality assurance requirements
- Understand GMP and GDP practices related to Quality Assurance and incorporate into training program
- Work with cross-functional stakeholders to review training curricula across job functions and levels
- Leverage innovative training formats and methods to engage trainees and generate understanding of and interest for QA compliance
- Collaborate with corporate training team and support training delivery
- Support the OPS Ireland quality leadership team as necessary, including assisting with agency audits and reporting
- Support the development and reporting of training related Key Performance Indicators (KPIs) including measurement of training completion status and training effectiveness
- Responsible for issuing, handling and storing of sites training records
- Stay abreast of industry QA and regulatory developments and standards, sharing with the teams as appropriate
- Manage training related investigations and implement Corrective and Preventive Actions (CAPAs) where necessary
Requirements
- Experience in scientific or other relevant field (or bachelor's degree equivalent)
- Working knowledge of industry guidelines including cGMP, Quality Assurance and regulatory guidelines (i.e., FDA, EU, ICH, ISO), and handling of regulatory inspections
- Experience in translating technical compliance requirements to experiential training documents and other formats
- Excellent written and verbal communication with ability to influence effectively at all levels within the organization
- Proficient in use of Microsoft Word, Excel, PowerPoint, Visio, MS Project, and Outlook
- Experience utilizing software programs including learning management systems (LMS), quality management systems (QMS)
- Proven experience in developing and delivering pharmaceutical training programs, preferably in a Quality Assurance or regulatory compliance environment
Preferred Qualifications
- Certification in training and development and quality management
- Experience in coordinating training initiatives for regulatory inspections and audits
- Experience working in a multinational pharmaceutical company
- Knowledge of international quality standards and guidelines
- Ability to work independently and collaboratively in a fast-paced, dynamic environment
- Ability to manage vendor and external manufacturing relationships interfacing with their quality affairs teams
- Strong attention to detail and a commitment to maintaining high-quality standard
What We Offer
At Optum, we offer a dynamic and supportive work environment that fosters growth and development. We are committed to providing our employees with the tools and resources they need to succeed in their roles. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.