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.
