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QA Technical Specialist

QA Technical Specialist

ConfidentialHyderabad / Secunderabad, Telangana
30+ days ago
Job description

Key Responsibilities -

Management Review

  • Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content.
  • Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA).
  • Lead 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.
  • Actively contribute 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.

    • Preferred 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.

    • Core Competencies

  • Leadership in Quality Governance (e. g. , Management Review)
  • Inspection Readiness and Compliance Assurance
  • Quality Data Visualization, Interpretation and Analytics
  • Technical Document Drafting and Workflow Ownership
  • Cross-Functional Stakeholder Engagement
  • Continuous Improvement Mindset

    • Basic Qualifications and Experience :

  • Master s degree with 5-9 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

    • Skills Required

    Technical Writing, Data Visualization

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