J&J Family of Companies Supplier Quality Auditor in Beerse, Belgium
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. 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.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
Summary of responsibilities:
Performs planned and unplanned Supplier audits (by means of on-site or other tools) to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides supplier compliance expertise to the organization as required.
Essential Duties and Responsibilities (Other duties may be assigned):
Assures that the supplier quality system audit function complies with QSR/GMP, ISO and other regulatory requirements.
Performs audits of suppliers for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
Ensures audit reports are issued within the prescribed time frame.
Performs supplier re audits of deficient matters and corrective actions, as needed and required.
Documents supplier audit results in written audit reports that are distributed and reviewed by appropriate management.
Can serve as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors.
Maintains files containing reports of supplier audits and re audits.
Provides direction and guidance to auditors in training and/or volunteer auditors.
Collects and reviews supplier audit metrics and communicates to sites and worldwide management. Generates data for management reviews.
Assists in formulating supplier procedures to be followed by the auditing group.
Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
Support JJRC base business projects and initiatives, as required.
Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Education and/or Experience:
BS in a related science or engineering field of study; and 8 or more years of related experience and/or training; or MS with 5 or more years; or Ph.D. with 3 or more years; or equivalent combination of education and experience. Proven ability to conduct and manage audits required. Computer Systems Validation experience preferred. Strong experience dealing with the Food & Drug Administration, MHRA, and/or other applicable health authorities inspections. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
Other Skills and Abilities:
Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ICH Q7, and ISO 13485 regulations is required. Ability to select, manage and direct a team during an audit, as applicable. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Strong statistical skills and manufacturing process understanding. Ability to lead a team through a root cause analysis problem. Ability to effectively present information to top management, public groups, and/or boards of directors. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others. Ability to stand firm while being open to new approaches. Ability to build partnerships both internally and externally. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to use PC's and associated Microsoft software. Ability to effectively interface with governmental and independent auditors. Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
The position will require approximately 60% travel both domestically and internationally. The ability to drive and to be comfortable with air travel are absolute requirements.
This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
This position may be based at any of the following Pharma facilities: Latina, Cork, Leiden, Schaffhausen, Geel, and/or Beerse.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)