Quality Assurance @ Sanand

2 days ago

Sanand, India KK HR services Full time

**Skill Required  **              :  Computer Proficient (Microsoft Office)

**Language Proficiency**         :   English, Hindi, Gujarati

**Job Knowledge**:

- Perform Installation Qualification, Operational Qualification and Performance Qualification activities
- Collect data during validation activities and performing basic test on equipment and processes under guidelines.
- Execute validation protocols for equipment, processes and system to ensure they meet industry regulations.
- Prepare validation documents such as protocols, test plans and reports, ensuring proper filing and maintenance of documents.
- Record test results, deviations and corrective action accurately and support the review of validation data.
- Ensure validation documentation complies with international standards and regulatory requirements.
- Adhere to GDP and internal quality management system while performing validation task.
- Ensuring compliance with ISO 13485, and other relevant regulatory guidelines in validation activities.
- Preparation of documents and records for internal and external audits.
- Addressing audit findings or corrective actions related to validation processes.
- Collaborate with cross functional teams, including manufacturing, engineering and quality assurance in validation activities.
- Control of record and documents as per QMS
- Prepare SOP and Quality procedure as and when required
- Review and compile Device History Records
- Prepare change control as and when required
- Review external test reports according to requirements
- Review equipment calibration certificates and assist calibration engineer as and when required
- Review and update calibration documents as per plan
- Coordinate with different departments for QA activities
- Other work assigned by superior

6353 076 225

Pay: ₹350,000.00 - ₹500,000.00 per year

Schedule:

- Day shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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