Shweta Thutan

As Quality assurance Officer with several years of experience in the Pharma industry. Adept at establishing requirements that meet quality assurance objectives and standards. Skilled at reporting QA results and project updates to management.

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.

M. Pharma - Quality Assurance - Bhagwan Mahavir College of Pharmacy