Validation Analyst

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.

Essential Job Duties:

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

Knowledge, Skills, and Abilities

MUST HAVE EXPERIENCE: 

• Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP
• Experience in electronic / paper-based execution methods 
• 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 / Veeva QMS or any QMS tool experience will be an added advantage.
•  HP ALM/ValGenesis/Kneat tool knowledge will be an added advantage.

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 family
• 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