Senior Validation Specialist

7 days ago

Solapur, Maharashtra, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000
Validation Engineer Job Description

About Us:

We are a leading software company with over 11.3 billion USD revenue, a global workforce of 240000 employees, and presence in 60+ countries.

Job Title: Validation Engineer

Location: HYderabad/Bangalore

Experience: 5 - 10 yrs

NoticePeriod: Immediate - 30 days

Mandatory Skills and Qualifications:

Required Education and Experience

• Bachelor's degree (B.S.) in related field or equivalent

• 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system

• Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards

• Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs

• Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools

• Understanding of FDA's recent guidance on transition of CSV to CSA

• Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills

• Ability to work on complex projects with general direction and minimal guidance

• Ability to handle multiple projects and meet deadlines

• Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

Preferred Skills and Experience

Hands-on experience with Microsoft word, Excel, PowerPoint & Visio

Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools

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