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Clincal Quality Auditor | Novartis | Greensboro, NC
A health care company with global reach. A product pipeline filled
to the brim. A team committed to scientific advancement.
Think what's possible.
A global leader in animal health, Novartis has one of the most exciting
product ranges and pipelines in the industry today. Our products are
brought to life by diverse, talented, performance driven people who are
passionate about animals. All of which makes us one of the most
rewarding employers in our field.
MUST BE A GCP EXPERT
Implement and maintain Quality Assurance compliance processes and
procedures to ensure high quality standards of Good Clinical Practice
(GCP) and Good Laboratory Practice (GLP).
1. Coordinates, plans, and conducts audits, issues audit reports and
reviews and approves correc-tion action plans and audit responses for
Clinical Research Organizations, Investigators or Study Representatives.
2. Maintaining quality systems, which include Good Laboratory Practice
(GLP) and Good Clinical Practice (GCP) to all customers within New
Product Development.
3. Providing quality assurance functions for New Product Development
(clinical and technical) to assure that all required documentation,
rationale, scientific justification, raw data is available, accurate,
and authentic, as required.
4. Reviewing, implementing and managing quality (New Product
Development) Standard Operating Procedures (SOPs) for Global Compliance
operations.
5. Managing project related documentation (e.g. study protocols/plans
and reports) including editing, proof reading of documents and data
verification (when appropriate).
6. Writing reports and SOPs when appropriate.
7. Providing training to current GCP and GLP guidelines
8. Perform any other duties or serve in such other capacity as may be
determined by Company management.
JOB REQUIREMENTS:
- Bachelor degree in Science (agriculture, biology or
chemistry) or related field (e.g. veterinary); (or equivalent
experience)
- Minimum 5 years in GCP regulated industry.
- Expert knowledge in GLP and GCP, and compliance in regulatory
requirements (FDA, EMEA, APVMA etc).
- Extensive knowledge of FDA rules and regulations.
- Working technical knowledge in one or more of the following fields:
analytical chemistry, parasitology, laboratories, and computer
compliance. Validation.
- Extensive knowledge of OECD and FDA principles of GLP, GCP and VICH
GCP guidelines.
- Extensive knowledge of compliance- auditing GCP & GLP
- Working knowledge of farm animal applied clinical development and
pre-clinical development.
- Working knowledge of animal welfare.
- Able to interpret regulations and policies, and to communicate and
respond to associated questions.
- Ability to define problems collects data, establish facts and draw
valid conclusions.
- Skilled in risk assessment methodologies and project organization.
- Ability to work additional hours as required
- Ability to undertake local, interstate & international business
travel as required
To learn about other Novartis opportunities, http://www.novartis.com/careers/
To apply for this position, please copy and paste the following link
into your browser address bar:
http://novartis.contacthr.com/20022214
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