Head Quality Assurance - Oral Solid Dosage (PSS06890)

About the Client: PSS has been mandated to hire a Head Quality Assurance - Oral Solid Dosage for a leading rapid-growth pharma organization.

Job Purpose: 

Ensuring organization control by simplifying responsibility in line with Quality processes to enhance production and business management.

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 organization's 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