Job Summary: As a Vendor Quality Support at our client Pharma SA, you'll provide expertise and support to Vendor Quality Lead professionals overseeing external manufacturing activities. Your role involves reviewing and assessing various quality-related aspects such as Product Quality Reviews, Stability Protocols, Quality Agreements, Deviations, Change Controls, Investigations, and more. This role covers global Neurology & Established Brands products, including intermediates, APIs, bulk, and finished drug products.

Major Responsibilities:

Review stability protocols and reports, communicate trends to Vendor Quality Lead.
Perform CMO PQR reviews, complete PQR Assessment, and discuss outcomes with VQL.
Participate in Quality Agreements (QAA) reviews and draft QAA as needed.
Review change controls, participate in our client Product Change Control Committees.
Assist with Validation and Technical Transfer protocols and reports.
Review Master Batch records changes and deviations, coordinate investigations.
Support audits preparation and risk-based evaluation of vendors.
Provide expert QA advice and support for technical operational QA matters.
Handle CMO Connectivity topics and issues.
Act as substitute for other Quality Vendor Support/Coordinator.
Ensure compliance with HSE and Corporate policies.

Education & Experience:

Bachelor's degree or equivalent.
5-10 years of quality experience in pharmaceutical industry.
Knowledge of pharmaceutical formulations and manufacturing.
Hands-on experience in failure investigations and root cause analysis.
Solid understanding of European Good Manufacturing Practices.

Competencies:

Strong English communication skills.
In-depth knowledge of global pharmaceutical industry regulations.
Ability to work autonomously and handle complex situations.
Effective interpersonal and communication skills.
Skilled in root cause analysis and risk management.
Independent analytical and decision-making abilities.
Ability to work across cultures and in a multi-cultural environment.

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