Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itslegacy for over a century. Mercks success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network thats committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Lead and perform internal audits (system and walkthrough) at the MSD site. Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals. Perform audits at regional MSD sites, and host regional guest auditors (as applicable). Lead by example and apply cutting edge, risk-based audit techniques. Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation. Support the preparation and hosting Health Authority inspections and Divisional GMP Audits. Generate and report metrics / trends for program adherence to requirements and effectiveness.
- Lead and perform site internal audit program for system and walk-through audits for all site operations
- Generate annual audit schedule using risk-based principles
- Perform forcause audits, review/approval of CAPA responses (including root cause analysis), and CAPA verification/effectiveness checks
- Perform audits with guest auditors from other MSD sites; participate in opportunities to audit at other MSD sites
- Collaborate other auditors at Divisional and Site level to maintain cutting edge compliance/regulation/auditing skills
- Generate observations and propose ratings, and overall Audit outcome rating
- Generate risk communication for Site (Quality Council)
- Achieve and maintain auditor expertise
- Generate metrics for audits, inspections, and CAPAs; propose any remediation required
- Generate annual audit/inspection performance report
- Actively participate in the Auditor Community of Practice and Guest Auditor Program at the Divisional level
- Bachelors Degree in Engineering, Biology, Chemistry or related field
- Minimum of 6 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
- Knowledge of US, ICH, and other international regulatory requirements, as applicable to the site
- Subject Matter Expertise, including knowledge and demonstrated application in one or more of the following areas, based on site activities: Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product
- Specific technical knowledge in areas pertaining to the site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiological testing, Data Integrity, Automation)
- Learning agility demonstrated ability to continually learn new technical, quality/compliance, & regulation knowledge and apply
- Act with Courage and Candor demonstrated ability and willingness to advocate for compliance position using objective evidence
- Collaboration ability to maintain productive communication channels with stakeholders
- Excellent verbal and written communication skills
Preferred Experience and Skills:
- GMP Audit experience in the Pharmaceutical industry
- Experience with leading and performing effective audits and obtaining meaningful audit observations
- Problem-solving / critical thinking ability to understand connections between different technical/quality system areas and recognize potential compliance issues
- Knowledge of QBD development & submission requirements, as applicable to site
- Knowledge of and experience in Quality Risk Management methods
- Experience with hosting or participating in Health Authority inspections and/or Divisional audits
- Ability to prioritize and balance work from multiple projects in parallel
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, were inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to(e-mail removed).
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Visa sponsorship is not available for this position.
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