Job Description

Division

Integrated Product Development

Department

Global Respiratory

Sub Department 1

Respiratory -Formulations R&D - DPI

Job Purpose

This role is expected to define the testing and validation scheme for medical devices at various stages of the development, implement such testing, verification of device performance and validation of robustness and safety of the developed devices, and document the relevant output to support filing and approval of these developed devices

Key Accountabilities (1/6)

Define product safety, quality, and compliance checklist for shortlisted projects

• Define a detailed checklist as per relevant SOPs, experience of other product files, and product specific guidance to evaluate safety, quality, and compliance of the shortlisted projects
• Detail the testing methodologies, standards, requirement of certifications and other department collaboration requirements basis the checklist

Key Accountabilities (2/6)

Make a verification and validation (V&V) plan and write suitable protocols

• Make a V&V plan by tasks, timelines, costing, external agencies vs inhouse facility
• Write, get reviewed and approved suitable verification protocols with ROC, QC, RA functions e.g. robustness, stability, safety and ISO compliances

Key Accountabilities (3/6)

Develop testing methods, jigs, and processes to implement the V&V plan and protocols

• Build testing jigs, setup, and measurement scheme to conduct validation studies and noting any anomalies or risks in the product at various stages of development
• Develop external labs, vendors, testing facilities required to carry out validation studies at prototype, scaled up or near commercial stage of product development.

Key Accountabilities (4/6)

Document, report the results of V&V and troubleshoot risks and issues the product

• Keep a concurrent record on ELN, CipDox or suitable record book in a compliant manner of the testing completed with observations if any
• Discuss with design team the risks, issues and areas of improvement identified in the product design/performance/features or parts to ensure that these risks are mitigated before the next iteration testing

Key Accountabilities (5/6)

Maintain technological competency in prototyping and testing facilities including periodic calibration

Maintain technological competency for the department in prototyping (e.g. 3d Printer, casting tools, metal proto machine etc.) and testing facilities including periodic calibration

Key Accountabilities (6/6)

Major Challenges

• Delay in feedback to the design team on risks, gaps, and performance issues in the product at various stage of design thereby resulting in a faulty device or a high salvage value
• Impact on tech transfer process due inaccurate or inadequate testing which does not comprehensively cover

Key Interactions (1/2)

• Cipla Devices team \xc3\xa2\xc2\x80\xc2\x9c device design understanding, critical quality attributes, tech transfer attributes
• Finance team- approval for testing budget, POs and exceptional capex items (weekly)
• Regulatory \xc3\xa2\xc2\x80\xc2\x9c testing and validation protocols, USP 661 etc. to be maintained (Weekly)
• QA/QC- relevant certification and documentation for medical devices under scale up ( Fortnightly)

Key Interactions (2/2)

• Mould manufacturers \xc3\xa2\xc2\x80\xc2\x9c scope, timeline and mould development management, FOT (Regular basis)
• V&V agencies, testing laboratories

Dimensions (1/2)

• 5-6 products at a time in the pipeline requiring V&V plan, testing execution and documentation
• 2-3 production processes and near commercial stage production requiring extensive validation and certification for filings

Dimensions (2/2)

Key Decisions (1/2)

Key Decisions (2/2)

Education Qualification

• Bachelor\xc3\xa2\xc2\x84\xc2\xa2s degree in mechanical, electronics, mechatronics, or industrial engineering
• Knowledge of statistical methods and analysis is a must

Relevant Work Experience

• 3+ years\xc3\xa2\xc2\x84\xc2\xa2 experience in design, validation, and testing of medical devices, drug-device combination at reputed pharmaceutical or medical device company
• Disciplined and well-organized in validation documentation (plans, requirements, drawings, design reviews, and test methods)
• Experience working with ISO requirements and other relevant guidelines and regulations (PPAP)
• Experience in medical device manufacturing (direct operations/team handling) highly welcome

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