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Must Have Skills (Top 3 technical skills only)*:

Excellent Understanding to Computer System Validation Process, Agile Change Management Process and SOP Management in Pharma Health care industry GAMP 5 Model Expertise and experience in FDA Audit Preparation Strong experience in creating validation Artifacts for GxP environment, creating SOPs and creating manual processes, guidelines

Nice to have skills (Top 2 only):

Excellent technical writing skills Excellent Technical writing skill

Detailed Job Description:

Review customers existing GxP procedures and conduct fit gap analysis Validation Artifacts for GxP environment Agile Change Management Process understanding

Minimum years of experience*: 1

Top 3 responsibilities you would expect the Subcon to shoulder and execute*:

Review customers existing GxP procedures and conduct fit gap analysis Design new procedures, SoP, templates and review Guide Development Team on documentation requirement and evidence collection and assist in FDA audit

Interview Process (Is face to face required?) Yes

Does this position require Visa independent candidates only? No