ERP
Sangeet Simachal
Executive Quality Assurance
Gadasanaput
Summary
Quality Assurance Executive with 6 years of documented quality Assurance success. Develops specific and measurable goals, improvements, and standards to continuously and consistently improve quality and reduce and eliminate errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.
Overview
6
6
years of professional experience
16
16
years of post-secondary education
Work History
Executive Quality Assurance
Signova Healthcare Pvt. Ltd.
07.2023 - Current
- Led a team of QA analysts, providing guidance, support, and mentorship to improve individual performance and overall team productivity
- Ensured compliance with industry standards and regulations by performing regular audits of software systems and documentation
- Execution of HVAC Validation
- Execution of Plant equipment & instrument calibration & Validation
- Review of BMR, BPR, MFR, MPR and COA
- Handling and management of documentation cell
- Implementation and review of MRP
- Implementation and review of Artwork.
Sr. Officer Quality Assurance
Eris Lifesciences Ltd.
12.2020 - 07.2023
- Preparation and compilation of Annual Product Review
- Preparation, Review and Distribution of SOPs and Formats
- Preparation and Review of BMRs/BPRs and MFRs and MPRs
- Handling and management of documentation cell
- To provide line clearance at various stages including Dispensing, Manufacturing and Packing activities
- To perform In-process quality checks
- To perform Swab sampling and analysis
- To perform calibration of IPQC instruments.
Officer Quality Assurance
V.S. International Pvt Ltd
12.2018 - 11.2020
- Issuance & retrieval of BMR, BPR, SOPs, Specifications, Logbooks and other documents.
- HVAC Validation data compilation.
- BMR, BPR & QC documents review for batch release.
- Preparation of PQR.
Education
Bachelor of Pharmacy -
Biju Pattnaik University
Bhubaneswar 07.2014 - 06.2018
CHSE -
PN Junior College
Khordha 07.2010 - 05.2012
BSE -
Saraswati Vidya Mandir
Khordha 04.2000 - 05.2010
Skills
Quality Management System
Multitasking
Teamwork and Collaboration
Quality assurance expertise
Documentation Control
Team Training
SOP Development
Decision-Making
Software
SAP
Microsoft Office
E-BMR & E-LOG
Languages
English
Intermediate (B1)
Hindi
Advanced (C1)
Odiya
Bilingual or Proficient (C2)
Cricket and Travelling
Cricket was my passion. Also love to travel places and meet new peoples as it gives me confidence and knowledge.
Additional Information
Audit Faced:
1. EU-GMP
2. WHO-GMP
3. NAFDAC
Timeline
Executive Quality Assurance
Signova Healthcare Pvt. Ltd.
07.2023 - Current
Sr. Officer Quality Assurance
Eris Lifesciences Ltd.
12.2020 - 07.2023
Officer Quality Assurance
V.S. International Pvt Ltd
12.2018 - 11.2020
Bachelor of Pharmacy -
Biju Pattnaik University
07.2014 - 06.2018
CHSE -
PN Junior College
07.2010 - 05.2012
BSE -
Saraswati Vidya Mandir
04.2000 - 05.2010
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