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Head Quality Assurance - Oral Solid Dosage
Head Quality Assurance - Oral Solid DosageConfidential • Shimla
Head Quality Assurance - Oral Solid Dosage

Head Quality Assurance - Oral Solid Dosage

Confidential • Shimla
30+ days ago
Job description

Key Responsibilities :

  • Ensuring organization control by simplifying responsibility in line with Quality processes to enhance production and business management
  • Developing SME for the right decision at the right time & Quality empowerment.
  • Leading the implementation of Quality initiatives, Risk & Change Management
  • Steering the Product Lifecycle Management for regulatory compliance & management control by deploying effective strategy and control on the following elements to the organizations quality :
  • Operation Review
  • Quality Assurance & Quality Control (Development & Commercial)
  • Audits and Regulatory Compliance
  • Project Management for Product Release
  • Product Reviews and Quality Review Board
  • Quality Philosophy
  • External Manufacturing Quality Assurance
  • Updates and Documentation Support
  • Automation initiative
  • Planning and Budgeting
  • Steering the development, review, approval, and implementation of SOPs related to quality systems.
  • Conceptualizing and implementing employee training effectively to enhance operational excellence
  • Active participation in client audits, health authority s audits; leading the Internal and Third Party Inspection Team
  • Heading the review and approval of the change management process and evaluation of the Quality matrix
  • Ensure Complaint management, escalation, market actions, actionable data reporting
  • Driving continuous improvement initiatives to foster a quality culture within the organization
  • Directing GAP assessments for a site for implementation of quality manuals & quality Governance directives
  • Facilitating planning and execution of the annual operating plan for business units & functions that addresses corporate strategic imperatives;
  • Developing quality management system.
  • Presenting to Chief Quality Officer on a monthly / Quarterly and annual basis quality dashboard across all sites.
  • Working closely with site quality Head and Creating Corporate Quality culture and Alignment.
  • Mentoring Site Quality Head for Overcoming Quality issues & establishing Comprehensive Quality MIS across all Sites.

Educational Qualifications And Experience :

  • Qualification : B. Pharma, M. Pharma, M.Sc
  • Experience : 18+ Yrs. Experience in OSD Facility
  • Skills Required

    quality processes

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    Quality Assurance • Shimla

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