| Developer - Pharma Audit Compliance : Omaha, USA(Hybrid) at Omaha, Texas, USA |
| Email: [email protected] |
| From: sachin chaudhary, K&K [email protected] Reply to: [email protected] Job Title: Developer - Pharma Audit Compliance Location: Omaha, USA(Hybrid) Role Description: As a Developer specializing in Pharma Audit Compliance, you will leverage your extensive experience in pharmaceutical audit processes, particularly focusing on SOX, GXP Applications, and Technical Platforms. With over 8 years of dedicated experience in this field, you will demonstrate a strong understanding of US FDA and other pharmaceutical regulations, ensuring adherence to the latest updates and requirements. Your role will involve leading assessment discussions with both corporate auditors and external audit teams, supporting data evidence phases for external governmental inspections, and driving improvements to achieve Zero Level 1/Level 2 Audit findings. Key Responsibilities: Utilize your 8+ years of pharma audit experience to lead assessment discussions with corporate auditors and external audit teams, ensuring compliance with SOX, GXP Applications, and Technical Platforms. Support the data evidence phase for external governmental inspections, providing necessary documentation and evidence as per regulatory requirements. Drive improvements within the audit processes to achieve Zero Level 1/Level 2 Audit findings, identifying areas for enhancement and implementing necessary changes. Assist in identifying, eliminating, or refining data requests that are obsolete or ambiguous, streamlining the audit process for efficiency and effectiveness. Develop a comprehensive BAP (Business as Usual) Audit Playbook, outlining audit procedures, requirements, and best practices for the organization. Train and mentor the audit team, with the goal of transitioning audit responsibilities over a period, ensuring continuity and competence within the team. Draft and update governance documents such as SOPs (Standard Operating Procedures), WIs (Work Instructions), etc., pertaining to backup, storage, platform, and Data Centers/Server Rooms. Build a self-service checklist for audit and inspection readiness, empowering teams to prepare effectively for upcoming audits and inspections. Design and drive closure of remediation activities resulting from audits, ensuring timely resolution of identified issues and deficiencies. Co-chair annual Business Continuity / Disaster Recovery Tabletop exercises, collaborating with relevant stakeholders to test and improve the organization's preparedness for potential disruptions. Competencies: Regulatory Reporting and Compliance Management Experience (Years): 8-10 years of relevant experience in Pharma Audit Compliance Essential Skills: Extensive experience in Pharma Audit Compliance for SOX, GXP Applications, and Technical Platforms Good understanding of US FDA and other Pharma Regulations updates Hands-on experience leading assessment discussions with auditors and external audit teams Desirable Skills: Certification or advanced training in Pharma Audit Compliance Experience in developing audit playbooks and governance documents Keywords: Colorado Developer - Pharma Audit Compliance : Omaha, USA(Hybrid) [email protected] |
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| Sat Mar 30 03:01:00 UTC 2024 |