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R&d Quality Principal Specialist Auditor in
2 settimane fa
Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson Family of Companies. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
JOHNSON & JOHNSON Consumer is the Worldwide leading Consumer Healthcare Company with the specific focus and mission to develop and market innovative OTC and consumer healthcare products and services.
Pomezia Plant is the biggest J&J Consumer Production Site in the World and a point of reference in terms of innovation and quality.
Do you want to join our team?
For our Consumer Health Care department, located in Santa Palomba - Pomezia (Rome), we are recruiting for a **Regional Franchise Quality Principal Specialist SH/EH** to be hired with a permanent contract.
The **Research and development Quality & Compliance (R&D Q&C) Principal Specialist** is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP) and within Johnson & Johnson policies and Standard Operating Procedures.
The Principal Specialist is responsible for developing and maintaining quality systems and controls related to GMP regulations and Johnson & Johnson policies and standards. He/She is responsible for review and approval of quality system documents, such as investigation, CAPA, change control, protocols and report.
He/She is also responsible for quality review/approval of NPD/LCM project related documentation including but not limited to protocols, process/analytical reports, method validation reports, test methods, specifications, deviations/investigations and APR review.
The Principal Specialist will also be responsible for general compliance support such as review and approval of standard operating procedures, batch records, packaging dossiers, Certificates of Analysis and release of study materials related to the projects.
Function as an advisor providing guidance on applicable Regulations (ISO, FDA, ICH, EU, and others) pertaining to business partners.
**Key Responsibilities**:
- Participate on R&D project teams as the Quality representative
- The Principal Specialist will work with these groups relative to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in compiling documentation to release R&D studies
- Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches. Responsible for the quality inspection or audit of supplies for R&D studies
- The Principal Specialist will evaluate current documentation, ensure compliance with J&J guidelines, company standards and European/local legislation, follow up, review and approve development plan and/or Change control or other appropriate documentation. The Principal Specialist will contribute to root cause investigation, review and escalation of deviations, OOS, NC and other critical issues during projects and follow up on resulting CAPAs, support in case of field actions (linked to design)
- Provide Quality guidance on GMP regulatory requirements including Training of R&D personnel
- End to End Q&C connection in project execution
- Support Strategic R&D initiatives
- Anticipate and proactively shape requirements adapted to the business needs, particularly to meet sustainability objectives
- Participate/lead in the development and implementation of GMP and Quality & Compliance processes and procedures
- Quality and compliance support for GMP R&D documentation management activities
- Responsible for Management and follow up of R&D suppliers
- Participate on and perform internal assessments of R&D GMP processes and areas. Participate in inspection readiness activities
- Quality and compliance support for qualification, validation, decommissioning activities for R&D equipment, instruments, utilities, and processes. Establishment of the site validation master plan
- Ensure Q&C support regarding any GMP topic from Pomezia R&D (OOS, NC, Change control, CAPA,..). The Principal Scientist will evaluate current documentation, ensure compliance with J&J guidelines, company standards and European/local legislation, follow up, review and approve Change control, laboratory investigation, investigation, or other appropriate documentation. The Principal quality engineer will contribute to root cause investigation, review and escalation of deviations, OOS, NC and other critical issues during projects and follow up on resulting CAPAs, support in case of field actions (linked
