Senior Quality Specialist – Life Science

WhiteCrow Research

  • Pune, Maharashtra
  • Rs. 5,00,000-6,00,000 per year
  • Permanent
  • Full-time
  • 13 days ago
About our client:Our client is a global leader in thermal energy management and specialized pumping solutions.They partner with customers to address complex manufacturing challenges by delivering advanced components and integrated systems that are both responsive and predictive. Their innovative technologies are trusted across a wide range of industries, including biotechnology, pharmaceuticals, industrial manufacturing, automotive, mining, food and beverage, OEMs, and medical devices. With operations in over 60 countries, they provide robust, worldwide customer support.Responsibilities:
  • Point of Contact for all quality matters, enquiries, and support to both internal and external customers
  • Develop, implement and align quality strategies to ensure processes and procedures meet quality excellence standards
  • Lead and mentor colleagues at sales operations offices, fostering a culture of excellence and accountability
  • Oversee the management of ISO 9001:2015 and quality system (CAPA, Change Management, Investigation, etc.)
  • Manage, own and investigate product complaints
  • Business Process Owner for Document Control
  • Analyse and track quality metrics such as Complaint KPI
  • Conduct/Host audits (internal and external) and inspections to ensure compliance with regulatory, quality and internal standards
  • Manage and negotiate quality agreements with end customers, group legal and global quality
  • Support quality documentation requests from customers
  • Ensure documentation and traceability of quality processes and corrective actions
  • Facilitate quality management reviews and relevant quality meetings
  • Manage supplier quality and conduct vendor assessments when necessary
  • Collaborate with cross-functional teams (e.g., global supply, sales, global quality, support teams) to resolve quality issues
  • Stay updated on industry trends, standards, and regulatory changes (where required)
  • Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies
Requirements:
  • Bachelor’s degree in Biological Sciences, Quality Engineering, or related fields
  • 5+ years of experience in quality assurance, quality compliance, supplier quality or quality operations
  • Strong knowledge of QA methodologies, tools, and standards (e.g., ISO 9001:2015, ISO 13485, cGMP/GxP relevant)
  • Auditor certification in quality standards preferred
  • Strong knowledge in investigation and RCA methodology, and technical writing skills
  • Proficiency in quality management systems softwares (e.g., Trackwise)
  • Excellent analytical, problem-solving, and decision-making skills
  • Strong communication and interpersonal skills
  • Able to work in fast-paced, dynamic environments
  • Detail-oriented with a strategic mindset
  • Independent, Proactive and Task-driven
  • Leadership experience preferred

WhiteCrow Research