QRC Representative – Ortho Clinical Diagnostics – France
Ortho Clinical Diagnostics (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 3,800 employees worldwide, and sales, marketing and logistics on six continents.
OCD was recently acquired by the Carlyle Group, a highly respected global asset management company, as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide.
The Career Potential
We are committed to enabling diagnostics to fulfill its vital role in the continuum of care and its importance as the focus of healthcare changes from treating sickness to promoting wellness. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. You will have access to a broad and exciting array of experiences, opportunities and new directions at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
As the company transitions, we are seeking for a QRC representative to join our team.
- Responsible for all the packaging customization and/or inspections processes associated to assigned products line(s)
- Support STEF in daily operations from a Q.R.C. standpoint for assigned product line(s)
- Assures compliance with internal policy and regulatory requirements of the assigned product line(s) from a Q.R.C. standpoint
- Check product-related activities carried out by the Third Party Logistics provider (breaking down, re-packaging, re-labelling…) and coordinate Local lot release and IVDD Lot Release for assigned product line(s)
- Support STEF-Logistic warehouse for specific projects , for assigned products line(s)
- Provide high QRC support to OCD affiliates
- Document all new procedures, create working instructions (S.O.Ps) as needed according to ISO 9001 version 2008 regarding specific QRC and STEF activities for assigned product line(s)
- Participate to the complementary labelling operations
- Deputise for the QRC Supervisor to approve COfAs
- Manage the assigned product line(s) from a Q.R.C. standpoint (Stop Shipment, In Bond/De Bond process, PAL, product release, packaging customization, rework/relabeling, cold chain management etc.)
- Support other product line(s) from a Q.R.C. standpoint in back-up situation
- Provide high quality support to our contacts in the country and to the STEF-Logistic warehouse, informing them on all-important Q.R.C matters
- Participate to the realization of the audit plan for external suppliers and internal audits
- Identifies, develops, recommends, and implements technical and process improvement.
- Assesses current systems and recommends improvements
- Demonstrates knowledge of operational processes affecting product quality
- Manages multiple tasks and priorities with minimal supervision
- Utilizes risk management and process excellence tools in order to identify risk factors in the quality system. Works with supervisor and others to determine mitigation plans
- Participate to/lead projects as requested by Management and QRC team
- EducationFive years + after bachelor degree
Specialized in Quality Management, Pharmacy Ph. D
- ExperienceTwo or three years experience of quality management preferably in a distribution context
Good understanding of current ISO9001, Good Manufacturing Practices & Good Distribution Practices.
Computer literate and working knowledge of software such as Word and Excel.
- Customer focused
- Well organized
- Good sense of priorities
- Good team player
- Good understanding of regulations (ISO, IVDD…)
- Excellent phone communication skills
- Fluent English and French
- Takes action and makes decisions that successfully build customer value.
- Uses appropriate measures to identify success.
- Demonstrates a clear bias for action on priorities.
- Makes complex issues easy for others to understand.
- Makes progress and remains focused under ambiguous and complex situations.
- Challenges the status quo to identify ways of doing things better and faster.
- Gives and receives constructive and candid feedback.
- Demonstrates ability to work with teams and others.
- Actively seeks feedback