Job Description

DesignationCONSULTANTNo. of Positions1Experience4.5-8 YearsSkill (Primary)INFORMATION SECURITY-REGULATORY COMPLIANCE MANAGEMENT-LIFE-SCIENCES (GXP, FDA, CSV, IQ/OQ/PQ)QualificationB-Tech (Posting).Job Role: External Consultant CSV Lead and Analyst
Contact Tenure: 06(Six) Months
Experience: Standard
Service Type: IT Validation
Skill Area: CSV
1. Mandatory Skills:
Excellence in CSV, Equipment Qualification
Hands-on experience with working in both Agile, waterfall and hybrid models.
Expert in performing validation activities for complex projects including authoring of end to end validation deliverables
Ability to support automation, cloud qualification, New IT projects wherever necessary
Expert in HP ALM, Azure, EDMS etc.
2. Optional Skills:
Good Communication both written and oral in English
Functional understating of the business applications
3. Roles & Responsibilities: Validation Lead
8+ years of experience in CSV
Able to perform Validation activities for the systems/applications from various business areas
Develop plans, execute, and deliver the services with acceptable service evaluations.
Able to perform CAPA and RCA using 5 x Why approach or any similar approach.
Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV.
Perform stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality.
Manage multiple concurrent tasks and be flexible.
Perform IT risk assessments.
4. Hiring manager . YSTS
Candidate Required onsite/Offsite/Hybrid- Hybrid(1.) Depending on the work environment, the subject matter expert may lead or be an active participant of a work-group with the need for specialized knowledge. (2.) Meet all agreed-upon turnaround times for deliverables, deliverable reviews, or deliverable sign-off (3.) Understands, articulates and implements best practices related to his area of expertise. (4.) Provides guidance on how his area of capability can resolve an organizational need and actively participates in all phases of the solution life cycle. Design Solutions and best practices to meet clients objective. (5.) Work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data

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