Project Quality Lead

Role & responsibilities

Project Quality Management

• Drive the management of the tubular quality innovation pipeline, from idea generation to implementation, to continuously improve product quality and performance.
• Define and implement action plans to improve quality standards for tubular parenteral packaging (AQL, vials, ampoules).
• Develop and roll out quality standards for products under development (e.g., microvials, dual-chamber solutions).
• Lead the validation and industrialization of new quality processes and technologies.
• Coordinate cross-functional project teams (Quality, Production, R&D, Regulatory, Purchasing).
• Support regulatory compliance and ensure alignment with industry standards.
• Propose and support investment projects related to quality innovation.
• Conduct risk assessments related to new technologies or quality improvements.
• Monitor and report progress of innovation projects to internal stakeholders (local and international).
• Participate in project kick-offs, risk assessments, and reviews for new tubular developments.
• Translate customer requirements (URS, technical specs) into clear quality deliverables (control plans, testing protocols).
• Define and validate project-specific quality control methods (visual inspection criteria, dimensional controls, cosmetic standards) for tubular glass products.
• Develop, maintain, and optimize quality documentation in collaboration with the Quality and Production teams.
• Apply project management methodologies (e.g., Stage-Gate) to ensure quality milestones are achieved.
• Establish acceptance criteria for dimensional (AQL), cosmetic, and functional specifications specific to tubular glass containers.

Product and Process Validation

• Plan and execute validation activities (IQ, OQ, PQ) for processes related to tubular glass new projects and products.
• Analyze validation data, interpret results, and issue comprehensive validation reports with recommendations for improvement.

Customer and Regulatory Compliance

• Ensure compliance with cGMP, ISO 15378, ISO 9001, and customer-specific requirements.

Cross-Functional Collaboration

• Act as the key quality interface between Quality, Innovation, R&D, and Operations during project execution.
• Support root cause analysis and implement corrective and preventive actions (CAPA) for project-related issues.

Preferred candidate profile

Experience - 12 to 18 Years

Qualification - BE / B. Tech in any stream

Salary - As per comp norms

Work Location - Vemula, Mahbubnagar (which is 100km from Hyderabad)

NOTE: Interested candidates can send their updated resume to [email removed].