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Validation Analyst

Validation Analyst

Sikich

2 - 5 years

3 - 8 Lacs

chennai coimbatore bengaluru

Posted:None| Platform:

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Skills Required

computer system validation 21 cfr part 11 fda gamp

Work Mode

Hybrid

Job Type

Full Time

Job Description

Sikich is seeking an experienced Validation Analyst to join our dynamic team and contribute to our commitment to quality and compliance in the field of computer systems validation.

Primary Job Responsibilities:

Develop/design OQ, PQ scripts along with RTM mapping
Perform dry run, formal execution and Issue re-testing
Maintain constant communication with management and peers
Create FRS, Validation plans, if required
Create any training repository and leveraging existing team's knowledge
Provide value adds to the project/organizations

Requirements:

Must Have Experience:

Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP
Experience in electronic / paper-based execution methods
TrackWise / Veeva QMS and HP ALM tool knowledge will be an added advantage
At least one year of experience in Life sciences domain and CSV

Must Have Life Skills:

Ability to multitask by handling more than one client project at the same time
Excellent Analytical and problem-solving skills
Proven understanding of existing project
Must be Self-driven as well as ability to learn, provide solutions both independently and with team is essential
Good communication ability and technical presentation ability (oral and written)

Technologies / Domain:

TrackWise is an added advantage
Knowledge of Scripting

Nice to Have:

Knowledge of the Agile methodology and experience working on a scrum team

Benefits of being a part of the team

Family Health Insurance including parents
Life & Accident Insurance
Maternity/paternity leave
Performance-based incentives
Referral Bonus program
Exam Fee Reimbursement Policy
Indian festival holidays
5 days working week
Doctor's Consultation

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