Process Validation Engineer

IDESLABS PRIVATE LIMITED

3 - 8 years

2 - 6 Lacs

hyderabad

Posted:3 days ago| Platform:

Apply

Skills Required

fda regulatory compliance quality systems process validation qms capa pq oq pharmaceutical usfda data validation quality control documentation iq gmp change control quality assurance manufacturing computer system validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities.

Roles and Responsibility

Perform gap assessments and conduct remediation of documents with stakeholder inputs.
Develop and maintain Manufacturing/Service Work Instructions and related documents.
Create/modify process flows within the Manufacturing/Service Departments.
Support the development and introduction of new products, processes, and technologies, focusing on quality systems.
Monitor and drive corrective action, CAPA, and continuous improvement activities impacting performance measures.
Implement corrective actions and support preventive actions in manufacturing using formal problem-solving tools and documentation.

Job Requirements

Good understanding of manufacturing-specific QMS documents for Class-I, II, and III medical devices.
Experience with statistics and effective communication for proper discussions.
Hands-on mentality to perform PV-related activities (e.g., TMV, IQ, OQ & PQ).
Knowledge of FDA 510 K, IS013485, ISO 14971 standards is preferred.
Ability to work in a fast-paced environment and adapt to changing priorities.
Strong analytical and problem-solving skills with attention to detail.

Additional Info

Interested candidates can share their profiles at or contact us directly.

More Jobs at IDESLABS PRIVATE LIMITED

Bank Fast Platform Engineer

Bengaluru

3.0 - 7.0 yrs

INR 5 - 9 Lacs

Risk Business Analyst

Bengaluru

5.0 - 10.0 yrs

INR 8 - 13 Lacs

Salesforce Commerce Cloud Professional

Hyderabad

3.0 - 5.0 yrs

INR 4 - 6 Lacs

Python Scripting with Terraform Professional

Hyderabad

3.0 - 5.0 yrs

INR 4 - 6 Lacs

Nodejs / AWS Developer

Hyderabad

3.0 - 5.0 yrs

INR 4 - 6 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.