Swathi Tammala
Quality Assurance Auditor
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About
Self-motivated Quality Assurance Auditor with outstanding oral and written communication skills, with in-depth Analytical Data Review expertise. Successful career history providing innovative solutions for quick project delivery. Successfully executes testing methodologies to identify gaps and make recommendations for process improvements. Leverages excellent analytical and programming skills to document and troubleshoot errors.
Experience
Assistant Manager - Biological E. Limited - Hyderabad
(2023-07)
Quality Assurance (Systems & Compliance)
- Play a key role in planning, conducting, and executing Internal Audits (Self-Inspections) on a monthly basis, and ensure timely closure of audit observations and reports.
- Prepare the Internal Audit Plan and ensure audits are conducted in accordance with the approved schedule.
- Participate in Vendor Audits and support the assessment of supplier compliance with applicable quality standards.
- Actively participate in Customer Audits and coordinate audit-related activities to ensure successful outcomes.
- Support and participate in Regulatory Audits, ensuring readiness and compliance with regulatory requirements.
- Prepare and maintain Change Control trend reports, including status of action items, CAPA implementation, and effectiveness checks.
- Prepare and analyze Deviation trend reports, including CAPA status, effectiveness checks, and identification of recurring issues for continuous improvement.
- Prepare Internal Quality trend reports, including audit observations, CAPA status, effectiveness evaluations, and overall compliance performance metrics.
- Preparation of Standard Operating Procedures (SOPs) related to the Quality Management System (QMS).
- Revision of key SOPs, including Change Control, Deviations, Internal Audits (Self-Inspection), and other quality system procedures.
- Revision and maintain the Site Master File to ensure compliance with current regulatory requirements and organizational standards.
- Providing Trainings to the personnel as a part of Induction Training or as a part of Refreshment Training and Auditor Qualification Program.
- Training and Evaluation of the new joiners of the Department.
- Training the Documentation personnel to minimize the Documentation errors.
- Conducting the Knowledge Sharing Sessions.
- Attending the External trainings on need basis.
- Issue Quality Risk Assessment Numbering, Contamination Control Strategy and maintain Log with up-to-date details.
- Preparation of QRA and CCS on QMS activities.
Quality Auditor - Vimta Labs Limited - Hyderabad
(2016-06 - 2023-06)
Quality Assurance (Systems & Compliance) & (Analytical)
Education
M.Sc. - Organic Chemistry - Osmania University (2012 - 2014)
B.Sc. - Botany, Zoology and Chemistry - Osmania University (2007 - 2010)
Intermediate - Board of Intermediate Education (2004 - 2005)
SSC - School of Secondary Education (2004 - 2005)