Jd

Conceives, plans and executes manufacturing process validations plans and studies.

Adhere to the Change Control and Design Control requirements.

To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's

Being the lead on the writing and execution of IQ/OQ/PQ protocols.

RCH/PCH - Routing in MAP Agile & follow up till release

Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD)

Preparing protocol & executing Test Method validation (TMV)

Validation experience using risk-based approach guidelines, international regulatory requirements, and standards

Quality And Compliance Related Responsibilities

Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations

Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.

Education

Degree qualified ideally science or engineering

Experience

Other further education and work experience may be considered

• Minimum 3-years' experience of working on manufacturing engineering validation activities
• Some previous experience in medical device or related regulated industry
• Experience in project management and project leadership
• Extensive experience in the preparation of technical documents
• Proficient in PLM tools & Microsoft Office
  
  

Personal Attributes

• Excellent written and oral communication skills
• Attention to detail
  
  

Ability to work as a team

Manage your own time and workload

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