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Specialist Iii, Qa Compliance
Company | BioSpace |
Address | Foster City, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-07-25 |
Posted at | 11 months ago |
United States - California - Foster City
- Experience with Biologics Products and Veeva QMS is a plus*
- Support regulatory inspection and mock inspection as required.
- Work with manager in developing and reporting trends based on internal and external regulatory observations to better focus the scope of supplier audits.
- Work with manager on incorporating sound risk management principles for the establishment of the annual audit schedule.
- Identify compliance risks and escalate issues to appropriate levels of management for resolution. Present escalations in stakeholder and management meetings.
- Manage all aspects of the audit lifecycle including scheduling, planning, drafting and issuing audit agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA and closing.
- Support risk assessments and supplier change management processes as required.
- Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team, as needed.
- Develop and maintain updates to the annual global audit schedule.
- Work with internal and external stakeholders in various supporting activities for audits.
- Work with manager to identify and drive non-CXO audit program improvements.
- Participate in the development, implementation and maintenance of procedures and templates to assist in the evaluation and auditing of suppliers.
- Ensure that the information for supplier is accurate in the system to drive accuracy of the approved supplier list.
- Create and provide audit attestations as needed.
- Manage the lifecycle of external supplier audit records in systems, ensure timely update and closure of audit records per procedural requirements.
- Support in training contractors/consultants who support the audit program.
- Review and approve audit reports.
- Create, publish and maintain metrics that measure the health and effectiveness of the audit program.
- Participate in audits and support projects
- Manage and process various activities in the Product Lifecycle Management system.
- Assist in development and continuous improvement of effective auditing tools and training aids.
- Manage and work with manager to triage new audit requests and due diligence assessments.
- Work directly with suppliers to ensure completion of correct CA/PA(s) to address compliance concerns identified during audits.
- Coordinate various audit supporting activities with third party audit service providers.
- Good understanding of system administration.
- Proficiency in Microsoft Office applications.
- Good verbal, written, and interpersonal communication skills.
- Audit and investigation skills, and report writing skills
- Good attention to detail, and ability to consistently meet standards required in Compliance.
- Ability to work both independently and in a team environment collaboratively.
- Solid working knowledge of Electronic Document Management Systems (EDMS).
- Solid understanding of the current pharmaceutical industry and applicable regulations and standards including 21 CFR, EU GMP, Health Canada, ICH, WHO, ISO etc.
- Good working knowledge of Quality Management System (QMS) fundamentals, processes, effects, and the relationship between the QMS and products.
- Good organizational skills and ability to work in a fast paced environment with tight timelines.
- Critical thinking skills.
- 6+ years of relevant experience in the pharmaceutical industry and GMP environment, and a BS or BA degree
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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