eCSV Senior Compliance Advisor

Rhian_Convatec; Reynosa; Presencial; MXN 1,108,000 - 1,478,000; Jornada completa

Descripción de la vacante

A global medical products company located in Reynosa, Tamaulipas, is seeking an eCSV Senior Analyst to oversee projects and ensure compliance with GxP regulations. The ideal candidate will have a bachelor's degree in a related field and experience in computer systems validation within the pharmaceutical or medical device industry. Strong communication skills in English are required to collaborate effectively with quality validation teams.

Formación

• Experience in computer systems validation.
• Knowledge of industry regulations and guidelines like GxP and 21 CFR Part 11.
• Experience in pharmaceutical manufacturing or medical device industry.

Responsabilidades

• Assess new computerized systems or software for GxP impact.
• Review changes to validated computer systems and identify necessary requirements.
• Perform periodic assessments to confirm the validated status of systems.

Conocimientos

GxP knowledge

Computer systems validation

Collaboration skills

Fluency in English

Educación

Bachelor's degree in computer science, engineering, life science, or a related field

Descripción del empleo

Overview

About Convatec Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

We’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.

Key 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.

Important Notices

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [e-mail].

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

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!