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Senior Quality Assurance Professional
3 weeks ago
- Ensure adherence to quality agreements with external partners, identifying performance improvement opportunities, and managing supplier relationships.
- Perform partner assessments related to Change Control and Deviation records, ensuring alignment with quality standards.
- Perform various QA tasks in support of Partnership Alliance Quality, including document revisions, redactions, and supporting partner audits in accordance with quality agreements.
- Assist with Due Diligence activities and other QA responsibilities related to Portfolio Strategy Execution.
- Collaborate with all key stakeholders for the end-to-end process and ensure compliance with GMP/GDP regulations throughout.
- Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP/GDP documentation in compliance with corporate and regulatory requirements.
- Partner with external suppliers and partners to ensure alignment with quality expectations and regulatory requirements.
- Incorporate risk management strategies into the overall external supply lifecycle to mitigate potential risks.
- Support tactical activities related to internal/external audits and inspections, ensuring compliance with regulatory standards.
- Participate in operational improvement initiatives, programs, and projects that drive efficiency and compliance.
- Own business metrics, conduct performance assessments, and manage key documents that reflect the health of external supplier and partner relationships.
- A Master's degree and 1-3 years of experience in related fields or a Bachelor's degree and 3-5 years of experience in related fields or a Diploma and 7-9 years of experience in related fields.
- Understanding of GMP/GDP requirements and their application in pharmaceutical quality.
- Familiarity with raw material compendial testing.
- Experience in overseeing the quality of suppliers or external parties.
- Strong technical writing skills with experience in documentation and regulatory compliance.
- Experience in Alliance Management, including managing external partnerships and ensuring quality across the supply chain.