Ecsv Senior Compliance Advisor

hace 3 semanas

Del Norte, México Covantec A tiempo completo

**About Convatec**Job Description SummaryWe're looking for an **eCSV Senior Analyst** with a strong focus on **GxP** to join our team. This is a unique opportunity to oversee projects, ensure all applicable regulatory and compliance requirements are met, and confirm that systems are defendable during an inspection. If you are passionate about quality assurance and compliance and want to be part of a team that directly impacts the integrity of our systems, we want to hear from you.**Main Responsibilities**:- Assess new computerized systems or software to determine their **GxP impact**, and provide guidance on a risk-based validation approach.- Review proposed changes to validated computer systems/qualified IT infrastructure and identify the necessary validation or qualification requirements.- Ensure all changes are implemented and documented in a compliant manner.- Perform periodic assessments to review and confirm the validated status of systems.- Oversee **GxP-impacting projects** to ensure all applicable regulatory and compliance requirements are met.- Establish and maintain the **Software Validation Master Plan (SVMP)** and archive validation documentation.- Ensure necessary employee training on the software.- Prepare and close all **CSV-related** deviations, discrepancies, and change control documents.- Evaluate IT service and solution suppliers.- Maintain up-to-date knowledge of evolving regulatory requirements and act as an information resource for teams.**Key Requirements and Competencies**:- Bachelor's degree in computer science, engineering, life science, or a related field.- Experience in **computer systems validation**.- Knowledge of and experience with industry regulations and guidelines, such as **GxP** and **21 CFR Part 11**.- Experience in the pharmaceutical manufacturing or medical device industry.- Experience with equipment/process validation lifecycle management.- Proficiency in developing validation documentation.- Fluency in English (verbal and written).- Strong collaboration and communication skills with Project and Quality validation teams.**Beware of scams online or from individuals claiming to represent Convatec****Equal opportunities**Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.**Notice to Agency and Search Firm Representatives****Already a Convatec employee?

  • Ecsv Senior Analyst

    hace 3 semanas

    Del Norte, México Covantec A tiempo completo

    **Key Responsibilities**:The Senior eCSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by...

  • Trade Compliance Annex 24 Senior Analyst

    hace 7 días

    Región Costa Norte, México Truck Hero, Inc. A tiempo completo

    ¡Estamos contratando! Trade Compliance Annex 24 Senior Analyst – Guadalajara, Jalisco ¿Tienes experiencia en Annex 24 y Annex 30 y te apasiona el cumplimiento normativo en comercio exterior? Únete a nuestro equipo en RealTruck y asegura el control automatizado de inventarios temporales, conciliación de movimientos y generación de reportes para...

  • Trade Compliance Annex 24 Senior Analyst

    hace 7 días

    región altos norte jalisco, México Truck Hero, Inc. A tiempo completo

    Overview ¡Estamos contratando! Trade Compliance Annex 24 Senior Analyst – Guadalajara, Jalisco ¿Tienes experiencia en Annex 24 y Annex 30 y te apasiona el cumplimiento normativo en comercio exterior? Únete a nuestro equipo en RealTruck y asegura el control automatizado de inventarios temporales, conciliación de movimientos y generación de reportes...

  • Gerencial Senior Fiscal

    hace 1 semana

    Playa del Carmen, Quintana Roo, México Skillia Talent A tiempo completo

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for a Senior Fiscal Manager (Gerencial Senior Fiscal) located in Playa del Carmen, ROO. The Senior Fiscal Manager will oversee and manage advanced fiscal operations and compliance activities. Responsibilities include preparing and reviewing financial...

  • Senior Project Engineer

    hace 4 semanas

    Del Norte, México Convatec A tiempo completo

    About ConvatecMain responsabilities:In general, the Senior Project Engineer is responsible for the Lead of a Project Team and has the authority of suggesting changes to the product in cooperation with Denmark (BUID) and the local organization (BUD).Project Engineering Leader in Production Transfer / Product changes.Contact person in Mexico when Denmark...

  • Senior People Partner

    hace 1 semana

    Del Norte, México Convatec A tiempo completo

    About ConvatecAbout the RoleThe HR People Partner is responsible for the execution, assignment, and follow up of the resources needed to carry out the strategy for HR functions as relationships, systems, tools & processes, and organizational capabilities for the Reynosa operations in the two facilities. It will be responsible of proposals, changes, and...

  • Senior People Partner

    hace 3 semanas

    Del Norte, México Covantec A tiempo completo

    **About Convatec**About ConvatecAbout the RoleThe HR People Partner is responsible for the execution, assignment, and follow up of the resources needed to carry out the strategy for HR functions as relationships, systems, tools & processes, and organizational capabilities for the Reynosa operations in the two facilities. It will be responsible of proposals,...

  • Project Senior Engineer, Facilities

    hace 1 semana

    Del Norte, México Convatec A tiempo completo

    The Senior Project Engineer is responsible for leading the planning, coordination, and execution of a cleanroom upgrade project. This includes managing cross-functional activities (production, work statement, transportation, installations, testing and commissioning of new infrastructure, facilities, equipment, technical scopes, contractor performance, and...

  • Local Mes Senior Iot Engineer, Reynosa

    hace 4 semanas

    Del Norte, México Covantec A tiempo completo

    **About Convatec****About the role**:The Local Senior IoT Engineer is responsible for implementing MES Smart Factory systems by enabling seamless connectivity between shop floor machines and the Manufacturing Execution System (MES). This includes configuring industrial machines (PLC, HMI, Testing Equipments, Stand-alone Product Printers, Machine interface...

  • Senior Injection Molding Engineer

    hace 3 semanas

    Del Norte, México Covantec A tiempo completo

    About Convatec**About the role****Main responsibilities**The technical lead is responsible for, but not limited to the following tasks:- Lead technical oversight of injection mold tool design, fabrication, and qualification to meet stringent medical device standards.- Ensure process control and consistency, including mold performance, dimensional accuracy,...