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Eng, Validation
hace 2 meses
Vantive: A New Company Built on Our Legacy
Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
**Main Activities and Responsibilities**:
- Monitor compliance with FDA regulatory requirements of countries to which product is exported, international standards (ISO 9001/ISO 13485) and corporate requirements with special attention to 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198.
- Statistical analysis of process variation, process/product control, risk analysis of plant product families, implementation of improvement actions resulting from analysis of internal and external product experience data.
- Ensure compliance with applicable regulations to maintain validation status.
- Perform qualification and validation process activities.
- Qualify critical equipment and systems used in manufacturing processes.
- Comply with the Validation Master Plan in force.
- Review validation protocols and reports.
- Collect information attached to validation protocols.
- Develop and maintain updated procedures applicable to qualification and validation processes according to corporate standards and national and international legislation.
- Be part of the decision making structure concerning regulatory compliance and quality standards in all the operations described above.
- Direct support in regulatory inspections.
- Supports Quality System compliance by participating in investigations as owner ensuring that activities related to NCR/CAPA follow-up are properly executed, completed and documented.
- In addition to in case of having participation as a quality approver has the responsibility to ensure that investigations have had adequate cause investigation and that investigation closures or actions have been properly executed, meet system requirements and are properly documented.
**Education**:
- Bachelor's degree level in the areas of Industrial Chemist, Chemical Engineer, Industrial Engineer or similar disciplines.
**Experience**:
- 2 -3 years of experience in Validations, qualification of manufacturing equipment and critical systems.
- 2-3 years minimum experience in process validation, analytical methods and computerized systems validation.
- 2-3 years minimum experience in quality assurance processes, audit execution and manufacturing process implementation.
**Knowledge**:
- Advanced English proficiency.
- Knowledge of computer systems, statistics, equipment qualification.
- Knowledge in basic statistics, Six Sigma methodology and risk assessment management.
- Knowledge of chemical and microbiological laboratory.
- ERP systems: SAP, TcU, JDEdwards.
- MDSAP. (Medical Device Single Audit Program) (Desirable).
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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