Change Control Specialist

Healthcare Businesswomen’s Association; México; Presencial; MXN 50,000 - 70,000; Jornada completa

Descripción de la vacante

A healthcare organization in Mexico is seeking a Quality Manager to oversee compliance in production and testing processes. The ideal candidate will have expertise in pharmaceutical quality assurance and a strong background in QC. Responsibilities include managing compliance, supporting investigations, and executing batch releases. Candidates should be skilled in operational excellence and continuous improvement.

Formación

• Experience in QC/QA in the pharmaceutical industry or biotech.
• Collaborating across boundaries with environmental monitoring.
• Understanding of cleanliness zones.

Responsabilidades

• Manage oversight of production and testing activities for compliance.
• Support exception investigations and improve operational excellence.
• Execute batch release in compliance with regulatory standards.

Conocimientos

Continuous Learning

Dealing With Ambiguity

Gmp Procedures

Qa (Quality Assurance)

Quality Control (Qc) Testing

Quality Standards

Self Awareness

Technological Expertise

Technological Intelligence

Descripción del empleo

Job Description Summary

Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Job Description

Major accountabilities

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS and T records
• MBR review
• Support OpEx improvement projects
• Qualified Person – Executes batch release in compliance with registration
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key performance indicators

• On-time and GMP-compliant release of dosage forms
• No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand
• Successfully support continuous improvement projects
• Executes batch release in compliance with registration

Minimum Requirements

Work Experience

• Functional Breadth
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &
• Collaborating across boundaries
• cleanliness zones

Skills

• Continuous Learning
• Dealing With Ambiguity
• Gmp Procedures
• Qa (Quality Assurance)
• Quality Control (Qc) Testing
• Quality Standards
• Self Awareness
• Technological Expertise
• Technological Intelligence

Languages

• English

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence