Lead Software Validation Specialist

1 week ago

Cochin, Kerala, India beBeeValidationEngineer Full time ₹ 1,00,00,000 - ₹ 1,56,25,000

About us:

We are a leading provider of software solutions, with a strong presence in India and across the globe.

Job Title: Validation Engineer

Location: HYderabad/Bangalore

Experience: 5 - 10 yrs

NoticePeriod:- Immediate - 30 days

Mandatory Skills:

Required Skills and Experience

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

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

• Knowledge of fundamental cGMP concepts and regulations, QSR, CFR Part 820, CFR Part 11, and ISO 9001 Standards.

• Strong knowledge of 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 recent guidance on transition of CSV to CSA.

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

Required Education and Training

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

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.

Benefits of this role:

We offer a competitive compensation package, comprehensive benefits, and opportunities for growth and development.

Key responsibilities:

  • Design, develop, and implement system validation plans.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Conduct training sessions for employees on GxP system.
  • Develop and maintain documentation for all system validation activities.
  • Provide input to quality improvement initiatives.

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