Technical Lead
Technical Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location:Northridge CA
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 & PQs
Being the lead on the writing and 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 riskbased 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.
Degree qualified ideally science or engineering
Other further education and work experience may be considered
- Minimum 3years 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
- Excellent written and oral communication skills
- Attention to detail
Manage your own time and workload
Excellent organizational skills
Employment Type
Full Time
