Quality & Compliance Specialist

The Pharmaceutical Regulatory Compliance organization is recruiting for a Compliance Specialist ! This position will be based in Geel .

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Pharmaceutica NV is part of the Janssen Pharmaceutical Companies.

Are you interested in making a difference in a growing diverse company? Apply today for this phenomenal opportunity!

This position will execute internal audit program at the pharmaceutical manufacturing sites, prepare for and support external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc.) and provide compliance subject matter expertise to the manufacturing sites and site based projects.

Key Responsibilities:

• Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
  • Execute compliance walk-throughs (e.g. GEMBA)
  • Evaluate responses to internal audits
  • Enter internal audit data in Internal Audit System
• Support external GMP audits and inspections (Health Authority, Customer).  Including:
  • Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
  • Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
  • Review site response and associated CAPA for Health Authority inspections
  • Provide input to daily inspection summaries, as needed"
• Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. 
• Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects.  As needed, review complaints and field actions.
• May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.
• Partner with site for execution of proactive compliance scans.
• Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site.  
• Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
• As needed, co-authors, review and revise compliance procedures.
• As needed, review (not approve) significant manufacturing and laboratory investigations, confirm complaints and S1/S2 Field Actions.
• Conduct Mock Recalls