Senior Quality Assurance Specialist

2 days ago

Pune, Maharashtra, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Senior Quality Assurance Specialist

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. This role will involve managing and reviewing expedited adverse events, product quality complaints, and medical information to ensure compliance with regulatory requirements.

Key Responsibilities:
  • Expedited Adverse Event Management: Manage and review expedited adverse event reports to ensure timely submission to clients and regulatory agencies.
  • Process Review and Audit Readiness: Conduct process reviews for assigned processes and monitor audit readiness to ensure compliance with regulatory requirements.
  • Training and Development: Support the design and tracking of training schedules and preparation of training materials for new hires and existing team members.
  • Quality Improvement: Contribute to discussion forums on quality errors within assigned projects and help identify process improvement opportunities.
  • Audit Coordination: Coordinate client or external audits of assigned projects as requested.
  • Quality Management Planning: Assist in developing the Quality Management Plan for assigned projects.
  • Regulatory Inspection Support: Collaborate with project teams to support clients during regulatory inspections at client sites, with guidance from the Quality Lead/Manager.
  • Data Analysis: Perform data analysis and suggest process improvement strategies if required.
  • Medical Information Query Response: Respond to or review medical information queries, product quality complaints, and general inquiries received via telephone, email, etc.
  • Information Accuracy and Compliance: Review recorded information from multiple communication channels to ensure accuracy and compliance.
Requirements:
  • Bachelor's Degree in a relevant field such as life sciences, pharmacy, or healthcare management.
  • Minimum 2 years of experience in quality assurance, regulatory affairs, or a related field.
  • Excellent analytical and problem-solving skills.
  • Strong attention to detail and organizational skills.
What We Offer:
  • Competitive salary and benefits package.
  • Ongoing training and professional development opportunities.
  • A collaborative and dynamic work environment.
About Us:

We are a leading [industry/company name] dedicated to delivering high-quality products and services to our clients. Our team is passionate about excellence and committed to making a positive impact in the lives of others.

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