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QA/Validation Engineer

Date: Feb 18, 2021

Location: Suzhou, 32, CN

Company: bioMérieux

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
Serves as a subject matter expert to provide guidance and expertise, and as a reviewer on account of quality viewpoint in regard to process technology transfer and product/system life cycle initiative. Recognize, develop and implement various essential validation activities based on risk assessment and user’s requirement.

MAIN ACCOUNTABILITIES:
1.Provide quality expertise in the project to compliance to local medical device regulations and relevance codes.
2.Participate and support in development on project plan, quality plan and validation plan activities, and raise
3.Serves as a member as a quality representative and chairperson for project control, and deliverable file review based on GxP and other relevant codes and regulations.
4.Assist cross function on the product and process risk assessment, identification and mitigation in project and along all the product/system life cycle.
5.Management with non-conformities, CAPA, drives root cause analysis on account of specific statically approach or tools.
6.Management with Change Control process, and support requisite re-validation or re-qualification activities through the product/system life cycle.
7.Execute internal/or supervise supplier validation activities in regard to project or validation plan, including supporting supplier or internal audit activities as necessary.
8.Assure quality records and documentations is generated, reviewed and approved in according to QMS procedure, and provide essential risk analysis and validation training to project teams as necessary.
KNOWLEDGE, LANGUAGE AND EXPERIENCE:
-Bachelor’s degree or above, Pharmaceutical science/engineering or related majors. At least 5 years’ experience in IVD, pharmaceutical or cosmetic related scientific field, served as project QA or/and validation engineer.
-Familiar with quality and validation relevant ISO codes, including ISO 13485, ISO 14971, ISO 14644, ISO 17665 etc.
-Knowledge of domestic pharmaceutical or medical device GMP, also be aware of EU or FDA GMP is as better.
-Good English oral and technical written ability, no communication barriers with US team.
-Familiar with CFR 21 Part 11 and GAMP is as better.
-Familiar with Lean and six sigma methodology is as better.