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
· Other further education and work experience may be considered
Experience
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