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Senior Quality Assurance Professional

3 weeks ago


Hyderabad, Telangana, India beBeeQuality Full time
**Job Title:** Senior Associate Quality AssuranceWe are seeking a seasoned Senior Associate Quality Assurance professional to join our team. As a key member of our quality assurance group, you will be responsible for ensuring compliance with quality agreements and supporting key partner and supplier assessments.Key Responsibilities:
  • 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.
**Required Skills and Qualifications:**To be successful in this role, you should have:
  • 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.
**What We Offer:**At our organization, we offer a competitive benefits package to support your health and well-being, opportunities for professional growth and career development, and a collaborative environment that values continuous learning and innovation.