Job opportuntiy to work as Operation Quality Lead at GSK-Apply before 30th April 2024


Website GSK

About GSK

GSK Pharma a global biopharmaceutical company, has a unique mission: to bring together science, technology, and talent to proactively combat disease collectively. This approach aims to have a positive impact on the health of billions of people while ensuring sustainable shareholder returns and creating an environment where individuals can flourish. Going beyond just treating diseases, GSK is committed to preventing them as well. The company’s ambitious goal is to improve the health of 2.5 billion individuals worldwide within the next decade.

Job Title: Operation Quality Lead (Value Stream)

Job Description:

  • Leadership: Lead a team of approximately 10 Operation Quality personnel, overseeing GMP/GDP/Quality activities on shifts at the site.
  • Quality Issue Resolution: Serve as the primary contact point for quality issues arising in manufacturing/packing operations.
  • Compliance Management: Ensure adherence to QMS requirements by conducting in-process checks, gap analyses, and risk assessments. Monitor manufacturing and packing operations to ensure compliance with validated and approved processes, promptly escalating any issues.
  • Inspection Readiness: Maintain continuous inspection readiness and ensure compliance with GxP and Data Integrity standards.
  • Quality Assurance Support: Provide timely support for Quality Assurance activities such as investigations and line clearances.
  • Document Review: Review and approve various documents including MFRs, BMRs, SOPs, Change Controls, and investigations into deviations/incidents/OOS results.
  • CAPA Management: Manage deviations, CAPAs, and their effectiveness, as well as trending analysis.
  • Quality Council Participation: Participate in Site Quality Council meetings, ensuring appropriate updates and discussions.
  • Regulatory Compliance: Ensure compliance with all regulatory and QMS requirements.
  • Operational Excellence: Actively participate in Operational Excellence activities to enhance QMS implementation across the site.
  • Audit Readiness: Ensure readiness for Level-3 and Level-4 audits, tracking CAPAs to ensure timely compliance.
  • KPI Tracking: Monitor Site Quality KPIs through the Inspection Readiness Dashboard.
  • Resource Management: Plan and allocate manpower and resources efficiently for Value Stream Operation Quality operations.
  • Team Development: Provide training and development opportunities for team members, focusing on job competency, knowledge enhancement, and personality development.
  • Stakeholder Liaison: Collaborate with stakeholders such as QC laboratory, Engineering, Technical, Warehouse, and Production departments on relevant matters.

Candidate Profile:

  • M.Pharm/MSc/B.Pharm qualification
  • Minimum 15 years of experience in Operation Quality, preferably in the pharmaceutical industry
  • Experience in Quality Assurance, IPQA, QMS, and Quality Oversight
  • Proficiency in Production, Validation, and QMS within the pharmaceutical industry
  • Strong skills in IPQA of Tablets and Creams & Ointments, Investigations & RCA, CAPA determination, Interpretational capabilities, and stakeholder management
  • Familiarity with qualifications and validations
  • Excellent written and verbal English skills, with advanced computer operational/usage capabilities

Additional Information:

  • Experience: 15 years
  • Qualification: M.Pharm/MSc/B.Pharm
  • Location: Maharashtra – Nashik Site
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Quality
  • Req ID: 392963
  • End Date: 30th April 2024
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