Quality Specialist

CSL; Morelia; Presencial; MXN 480.000 - 640.000; Jornada completa

Descripción de la vacante

CSL Behring is seeking a Quality Specialist to ensure 3PL operations meet local COFEPRIS regulations and CSL Behring policies, sustaining product quality through reception, storage, and distribution.

You will monitor cold chain, manage documentation, and coordinate QA activities across sites, with primary duties at 3PL facilities and occasional CSL Behring offices.

Formación

• Master, Bachelor, or equivalent degree in life-sciences (Pharmacy Preferred).
• Minimum 4 years of professional quality experience in a multinational pharmaceutical company.
• Experience managing quality electronic systems (TrackWise, VeeVa, etc.) and SAP ERP.

Responsabilidades

• Oversee product reception at 3PL in accordance with procedures and quality agreements.
• Review artwork/labels and validate temperature records.
• Oversee self-sampling processes per COFEPRIS-authorized procedures.
• Ensure documentation aligns with quality systems and CSL Behring requirements.
• Manage temperature excursion events and cold chain documentation.
• Coordinate certificates of analysis and retention samples with analysis labs.

Conocimientos

Target oriented

Interpersonal skills

Negotiation

Communication

Integrity

Bilingual EN/ES

Educación

Master or Bachelor in life-sciences (Pharmacy preferred)

Herramientas

TrackWise

VeeVa

Plateau

SAP

Descripción del empleo

The Quality Specialist ensures that all operations covered by the Third-Party Logistics provider (3PL) are conducted in full compliance with local regulations (including COFEPRIS), global CSL Behring policies, and current Good Distribution Practices (cGDPs). The role safeguards product quality integrity throughout the supply, storage, and distribution chain.

REPORTING RELATIONSHIPS

• Reports to: Local Quality Officer
• Direct Reports: None

Main Responsibilities & Accountabilities

• Product Reception at 3PL
• Supervise product reception at the 3PL in accordance with procedures, quality agreements, and applicable policies.
• Review artwork and labels of packaging materials and validate temperature records (data loggers).
• Oversee self-sampling processes in compliance with COFEPRIS-authorized procedures.
• Documentation Management
• Ensure all 3PL procedures and documents impacting CSL Behring products align with CSL Behring requirements.
• Verify that documentation generated during 3PL operations complies with Good Documentation Practices, quality agreements, and applicable policies.
• Transport Release
• Review and evaluate temperature records during transportation from Source of Manufacturing (SoM) to 3PL and during local distribution.
• Perform formal Transport Release (TVF).
• Cold Chain Management
• Monitor compliance with product temperature specifications at the 3PL and during local distribution, ensuring data loggers are included in all shipments.
• Support customers in the event of temperature excursions.
• Manage temperature excursion events within 3PL operations.
• Ensure qualification and/or validation of transport and passive packaging from SoM to 3PL, from 3PL to customers, and from 3PL to analysis laboratories.
• Review and support testing of the 3PL cold room qualification.
• Quality Assurance (QA)
• Submit product analysis requests to the analysis laboratory and coordinate sample collection.
• Administer reference standards in accordance with procedures, quality agreements, and applicable policies.
• Review Certificates of Analysis (CoA) issued by the analysis laboratory.
• Ensure retention sample management for CSL Behring products meets internal requirements.
• Coordinate delivery of Certificates of Analysis to Customer Services per applicable requirements.
• Product Returns
• Conduct returned product inspections.
• Execute SAP transactions in accordance with return assessment outcomes.
• Notify relevant CSL Behring and 3PL stakeholders of return destinations.
• Quality Systems Support
• Support quality system processes including: Complaints, Counterfeits, Deviations, CAPAs, Documentation, Product Recall, Annual Product Reviews, Product Release, and Change Control.
• Operate computerized Quality Management Systems: TrackWise, VeeVa, and Plateau.

Education

• Master, Bachelor, or equivalent degree in life-sciences (Pharmacy Preferred)

Experience

• Minimum 4 years of professional experience in Quality in a multinational innovative pharmaceutic al company.
• Management of quality electronic systems (TrackWise, VeeVa, etc.)
• ERP Management (SAP)

Competencies

• Target oriented and ability to work under pressure to meet deadlines and qualitative objectives.
• Strong interpersonal skills
• Good negotiation and communication skills
• A character of loyalty and integrity
• Fluent in English and Spanish (speaking and writing)

Additional Notes

The majority of activities will be performed at 3PL facilities. The Quality Specialist may also be required to conduct activities at CSL Behring Mexico offices as business needs dictate.