Shtakshi Banta

10+ years' professional experience with increasing responsibilities in several function of Quality Assurance. Detail and quality oriented professional, dedicated to ensuring the production of products free of defects.

Quality management System Senior Officer - Glenmark Pharmaceuticals Ltd.

(2023-03)

Effective implementation of Quality Management System at site. Management of Change Controls and ensure implementation of actions identified in a timely manner. Management of Deviations. Investigation of Failures and ensure effective implementation of CAPA along with effectiveness verification of CAPA. Implement and maintain Quality Risk Management System to ensure control of risks in accordance with current regulatory requirements. Preparation of trends of quality indicating parameters.

• Handling various Track-wise as well as SAP activities (change control, Deviation, CAPA, incident, risk management, incident, OOS investigation etc.). Managing SAP activities for APQR data.
• Evaluated, recommended, and approve changes of forms and reports. Escalate change control to Regulatory department which requires regulatory filing/variation filling.
• Documented findings of study and prepared recommendations for implementation of new systems, procedures, or organizational changes.
• Handling of Vendor and supplier management.
• Collaboration with other internal stakeholders and CFTs for quality improvements of products.
• Preparation of Risk Assessment (Proactive and reactive). Provided guidance on process improvements, and continuous improvement initiatives.
• Drives initiated for built better quality culture at site. Monitoring of relevant policies and procedures and updating of all SOP's based on revised internal / external requirements (Regulatory expectation).
• Investigated customer feedbacks related to product and service quality issues and generated corrective actions accordingly.
• Identified root causes behind issues facing client organizations and recommended solutions.
• Implemented corrective action plans for identified non-conformances in accordance with applicable regulations.
• To ensure compliance of current Good Manufacturing Practices & to follow GDP with data-integrity compliance.
• Performing investigation by using investigational tool and find out exact root cause to avoid reoccurrence.
• Ensures that complaints, errors, accidents and deficiencies are documented, controlled, and investigated as appropriate and that corrective actions are implemented when required.
• Responsible for compliance of safety norms at its work place.
• Preparation of Quality management system trends.
• Ensure site readiness by internal inspection and implementation of regulatory expectation.
• Quality culture initiative taken to develop and sustain the quality culture at site by continuous training program.

Executive Quality Assurance - Innova Captab Ltd.

(2021-11 - 2023-03)

Implementation and monitoring of Quality Management System to ensure compliance in accordance with current regulatory requirements. Review and Approval of Change Controls, Deviation, CAPA and Preparation of trends of quality indicating parameters. Investigation of failures (unplanned deviations, OOS & OOT), establish root cause and suggest necessary CAPA along with effective implementation.

Executive Quality Assurance - Pinnacle Life Science

(2021-03 - 2021-10)

Review and Approval of Change Controls, Deviation, CAPA and Risk Assessment Reports. Preparation of trends of quality indicating parameters. Investigation of failures (unplanned deviations, OOS & OOT), establish root cause and suggest necessary CAPA along with effective implementation.

Quality control Associate - Dr. Reddys Laboratories

(2015-04 - 2021-03)

Having hands on experience in Quality control of various dosage forms viz. Solid Oral Dosage Forms, Semi Solid Dosage Forms. Initiation of incident, OOS and OOT & Investigation of failures (unplanned deviations, OOS & OOT), establish root cause and suggest necessary CAPA along with effective implementation. Preparation of Change Controls, Deviation and CAPA.

M.SC - Chemistry - Maharaja Agarsen University (2020 - 2022)

B.SC - Pharmaceutical Chemistry - Chitkara University (2012 - 2015)