Stability QC Manager and Team Lead (GMP)

Viatris

Vega Baja (PR)

On-site

USD 120,000 - 180,000

Full time

7 days ago

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Job summary

Viatris Pharmaceuticals LLC in Puerto Rico is seeking a results-driven Manager/TL Quality Control, Stability to lead the stability QC analytical laboratory and its personnel. The role ensures cGMPs, GLPs and regulatory requirements are followed across the stability program.

Responsibilities include building a compliant QC organization, developing systems and procedures, supervising staff, reviewing specifications, supporting regulatory inspections, and ensuring data integrity and effective

Qualifications

Develops a QC organization for stability testing to ensure conformance with regulatory requirements.
Directly responsible for development and implementation of QC Systems in the stability laboratory.
Reviews procedures and maintains the quality management system and documentation.
Provides guidance during investigations of questionable results and OOS.

Responsibilities

Oversee stability testing operations and ensure adherence to cGMP, GLP and regulatory guidelines.
Review and approve stability protocols, reports, and data; maintain data integrity.
Lead and develop QC staff, provide mentorship, and ensure training compliance.
Support regulatory inspections and interactions with health authorities where needed.
Maintain risk management and continuous improvement in the stability program.