Senior Validation Professional

1 week ago

Bikaner, Rajasthan, India beBeeValidation Full time US$ 10,95,000 - US$ 15,23,000

About us:

We are a leading technology firm with over 11 billion dollars revenue, a global workforce of more than 240 thousand employees, and presence in 60+ countries. We deliver end-to-end technology, consulting, and business process services to clients across the globe.

Job Title: Validation Engineer

Location: HYderabad/Bangalore

Experience: 5 - 10 years

Notice Period:- Immediate - 30 days

Mandatory Skills:

Required Skills and Experience

- Bachelor's degree (B.S.) in a 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.

Required Education and Training

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

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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