Quality Assurance Executive - NGB Laboratory Pvt. Limited - Surat, India
(2024-03)
- Maintained accurate records regarding quality assurance activities such as inspection results, process validations.
- Reviewed manufacturing documentation including drawings, specifications, instructions for accuracy and completeness.
- Developed and implemented quality assurance policies, procedures, and processes to ensure product compliance with established standards
- Prepared technical documents including Summary Technical Documents, Clinical Evaluation Reports and Design Dossier.
- Review artwork according to the guideline.
- Assisted in the preparation of regulatory submissions by providing technical writing support
Quality Assurance Officer - Globela Laboratories Pvt. Limited - Surat, India
(2023-05 - 2023-10)
- To prepare the process validation, hold time protocol, and its report.
- Prepare quality-related documents like SOPs, Quality Risk Management reports, APQR, and others.
- Handling vendor qualification activities.
- Participating in stability activities, like withdrawal and charging the stability samples.
- Developed and implemented quality assurance standards for all processes.
- Assisted in the development of training materials related to quality assurance policies and procedures.
- Maintained records of inspection results, test data, non-conformance reports for review by management team members as needed.
- Ensured that employees are properly trained in safe working practice and adhere to established procedures.
- Identified problematic areas deviated from quality standards and recommended corrective actions.
- Created, edited, and updated project manuals and technical documentation used by entire QA team.
Quality Assurance Executive - NGB Laboratory Pvt. Limited - Surat, India
(2021-01 - 2022-03)
- Reviewed documentation such as work instructions, test protocols, reports to verify accuracy and completeness prior to release.
- Provided technical guidance and support to other departments on quality assurance related matters
- Assisted in the development of training materials related to quality assurance policies and procedures.
- Kept records of quality reports and statistical reviews.
- Updated and maintained documentation related to quality assurance processes, procedures, and reports to ensure regulatory compliance.
