Quality Specialist

OE -Team Member (Injectable)

Company Description

NA

Job Description

Job Description – OE Team Member (Injectables), IPDO

Role Overview

The OE Team Member – Injectables will support OE execution across Injectables R&D, focusing on right‑first‑time development, complexity reduction, and delivery reliability in quality‑critical and compliance‑driven environments.

Key Responsibilities

• Execute OE diagnostics across Injectables / sterile development value streams.
• Apply structured problem solving to reduce variation, rework, and development delays.
• Support standardisation of development practices, reviews, and cross‑functional handoffs.
• Drive improvement initiatives focused on quality, delivery predictability, and risk mitigation.
• Partner closely with formulation, analytical, quality, and PMO teams to enable adoption.
• Track PQDSCM metrics with emphasis on quality and delivery.

Required Skills & Experience

• 3–6 years of experience in OE / Process Improvement / Injectables / Sterile R&D / regulated environments.
• Exposure to Injectables / Parenteral / Sterile development strongly preferred.
• Knowledge of Lean, Six Sigma DMAIC, and risk‑based problem solving.
• High attention to detail and comfort in quality‑critical environments.

Success Measures

• Improved right‑first‑time outcomes and reduced development delays.
• Sustained adoption of standard practices in Injectables R&D.
• Improved delivery predictability and quality metrics.

Additional Information

Key Responsibilities

1. OE Strategy Deployment Support

• Support deployment of the IPDO OE strategy within the API R&D value chain through disciplined execution of improvement initiatives.
• Translate API‑specific OE priorities into project charters, detailed workplans, timelines, and success metrics.
• Support assessment of new API programs, route changes, or technology choices for OE impact and DLSS alignment.

2. Transformation Methodology Execution (DLSS Framework)

• Execute OE initiatives using Design Thinking, Lean, and Six Sigma (DMAIC) methodologies across API PD and scale‑up workflows.
• Apply structured problem‑solving tools to identify root causes of yield loss, variability, rework, and cycle‑time delays.
• Support development and application of DLSS tools, templates, SOPs, and best‑practice playbooks relevant to API R&D.
• Participate in OE capability‑building initiatives through hands‑on execution and learning.

3. Design Thinking & Solution Development

• Conduct human‑centric diagnostics by engaging scientists, project teams, and downstream stakeholders.
• Support co‑creation workshops, ideation sessions, and rapid prototyping to address API development pain points.
• Translate insights into practical, scalable, and manufacturability‑aligned solutions.

4. Project Execution & Value Realisation

• Execute assigned OE projects end‑to‑end, from diagnostics through implementation and stabilization.
• Track milestones, interdependencies, risks, and benefits realisation for API OE initiatives.
• Support benefit quantification across yield improvement, cycle‑time reduction, productivity, and cost.
• Ensure improvements are embedded, standardised, and sustained post‑implementation.

5. Continuous Improvement (Lean + Six Sigma)

• Support execution of DMAIC projects, Kaizens, A3 problem solving, VSMs, and waste elimination initiatives.
• Assist in deployment of standard work, visual management, and performance governance mechanisms.
• Support OE KPI tracking and data‑based insights for reviews.

6. Knowledge Management & Communication

• Document OE learnings, case studies, and best practices for DLSS knowledge repositories.
• Prepare dashboards, progress updates, and review materials for OE governance forums.
• Support communication of OE outcomes within the API R&D community.

7. Stakeholder & Change Enablement

• Partner with API PD, Analytical, PMO, and Manufacturing interface teams to drive adoption.
• Support change management through pilots, training sessions, and on‑ground enablement.
• Act as a problem‑solving partner during implementation to ensure momentum and closure.