.The Pharmaceutical Regulatory Compliance organization is recruiting for a **Compliance Specialist**!
This position will be **based in Puebla, México.
****You will be responsible for**:- 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 to TrackWise"- 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.
**Qualifications** Qualifications, Experience and requirements**:**Education**:- Bachelor's Degree in Science or related field**Experience and Skills**:**Required**:- At least 5 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience.- Knowledge of global GMP regulations is required.- Strong analytical skills.
Ability to clearly articulate issues.- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.- Delivers on commitment timelines and has high sense of urgency.
**Preferred**:- QA/RA certification is preferred.- Experience performing internal or external audits is preferred.
**Other**:- Requires up to 10-15% domestic travel.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
**Primary Location**Mexico-Puebla-Huejotzingo- **Organization**Janssen Cilag S.A. de C.V