Quality Assurance Professional

23 hours ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 13,08,780

Quality Assurance Specialist Role

This role requires a seasoned Quality Assurance professional to lead and coordinate quality-related activities within our organization. The successful candidate will be responsible for ensuring compliance with regulatory requirements, identifying and mitigating quality risks, and driving process improvements.

  • Key Responsibilities:
  • Coordinate and manage all logistics related to site management reviews, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content.
  • Perform site-level and cross-site trend analysis using key quality metrics; identify trends and collaborate with stakeholders to implement corrective and preventive actions (CAPA).
  • Lead the preparation of management review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items.
  • Inspections and Compliance:
  • Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence.
  • Contribute actively during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts.
  • Lead site master file updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows.

Technical Writing and Data Analytics:

  • Lead authoring and workflow coordination for periodic quality trend reports and related documentation.
  • Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards.
  • Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards.

Required Skills and Qualifications:

  • Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles.
  • Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.
  • Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights.
  • Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices.
  • Excellent verbal and written communication skills, including experience presenting to senior leaders.
  • Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.

Benefits:

This role offers a unique opportunity to work with a talented team of professionals who are passionate about delivering high-quality products and services. If you are a motivated and experienced Quality Assurance specialist looking for a new challenge, we encourage you to apply.

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