DirecciónThis is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your role at Baxter:
Responsible for activities to develop and execute validation and qualification protocols to comply with Baxter's internal policies and international standards, as well as strengthen continuous improvement in manufacturing and production processes for critical plant services.
Key Activities and Responsibilities: This section lists five to eight major job responsibilities. The individual will perform additional duties as assigned.
This is a Quality Assurance and Regulatory Affairs Engineering position, with activities to promote continued compliance with ISO13485 and FDA Law (all) but with special attention to 21CFR 820.1, 5, 20, 22,30(h) 30(i), 40, 100, 120, 180, 181 and 186, and the analogs of 13485, (MDSAP) for medical device manufacturing. The position has the responsibility to have a detailed System to coordinate and execute activities in TCU and TW, as well as to support Management in the coordination of the Validation Program, CAPA Actions, (Corrective and Preventive), Verification Actions, according to the QMS and regulatory compliance of the Systems area, in its applicable elements and the Systems involved in the realization of the product, as well as the correct traceability, Change controls, Perform with a high sense of Discipline, Commitment and Responsibility, in a good working environment.
1. Serves as a backup for the position of Validation Supervisor.
2. Supports in the supervision of his group of engineers to achieve department objectives and ensure compliance in the execution of Validations.
3. Ensures that sampling plans are correctly applied in validations.
4. Responsible for the review of protocols against procedures.
5. Responsible for the review and approval of interim reports and opinion in validations.
7. Monitor compliance with FDA regulatory requirements of countries to which the 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, MDSAP.
8. 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.
9. Ensure compliance to applicable regulations to maintain validation status.
10. Perform qualification and validation process activities.
11. Qualify critical equipment and systems used in manufacturing processes.
12. To comply with the Validation Master Plan in force.
13. Review and approve validation protocols and reports.
14. Collect information attached to the validation protocols.
15. Maintains the software validation program.
16. Develop and maintain updated procedures applicable to qualification and validation processes in accordance with corporate standards and national and international legislation.
17. Provide compliance to GAMP 5, Annex 11 EC, CFR 21 part 11 and international standards focused on computer system validation and data integrity enforcement.
18. Report metrics in charge of your area in Validations. 19. Support the Internal Audits program. 20. Interact directly with your immediate boss, in a Loyal, Honest manner, maintaining a high sense of involvement with transparency and communication in all day to day activities. Maintaining a good working environment. Must prevent possible impact on the non-compliance of local and global metrics, where the Validations and Regulatory Affairs area is involved. Interacts frequently with all levels of Supervision and Management Staff, as well as key personnel, providing clear and accurate information that could impact the manufacturing of the product realization.
23. Ensure qualification and operation of controlled areas within applicable environmental specifications.
24. Ensure compliance status on documents that apply to training in accordance with each employee's curriculum load and own BaxU system. 25. Directly responsible for ensuring that new entrants must complete their BaxU training prior to performing departmental activities involving receipt inspection activities such as component release, segregating material to MRB.
26. NCR Investigations, CAPA assigned and/or delegated by their immediate manager, shall have high sense of priority among their activities, since effective follow-up and closure in a timely manner,
27. Be part of the decision making structure concerning regulatory compliance and quality standards in all the operations described above.
28. Direct support in regulatory inspections and external audits.
29. Comply with Health and Safety, ISO 14001 (Environmental Management) systems and in accordance with NOM-041, as well as those applicable.
30. To apply and follow EHS guidelines in accordance with established procedures, standards and official Mexican norms.
31. Use assigned personal protective equipment (PPE) in accordance with NOM-017.
32. Supports Quality System compliance by participating in investigations as owner ensuring that activities related to the follow-up of an NCR/CAPA are properly executed, completed and documented.
33. Is responsible for communicating to his supervisor any event or nonconformity identified in validation tasks.
What you’ll be doing:
Advanced English
Knowledge of computerized systems, statistics and equipment qualification.
Knowledge in the validation of computerized systems and processes, environmental control and application oflocal and international regulation applied to document control and audit processes.
Knowledge of the basic Minitab statistics annex, Six Sigma methodology and management of evaluation ofrisk.
ERP systems: SAP, TcU, JDEdwards.
Knowledge of receipt inspection systems, MRB-Quarantine.
Knowledge of problem-solving methodologies.
MDSAP. (Medical Device Single Audit Program)
Knowledge of ISO 13485 & CFR'S'.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
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.
