SUNITI S PANDEY
Ahmedabad
Summary
Results-driven QA Officer with Aculife Healthcare Pvt. Ltd., skilled in SAP (System Application Product in Data Processing) and root cause analysis and regulatory compliance. Proven track record in developing documentation templates and implementing corrective actions, enhancing inspection processes and upholding safety standards.
Overview
3
3
years of professional experience
1
1
Certification
Work History
QA Officer
Aculife Healthcare Pvt. Ltd.
06.2016 - 02.2019
- SAP (System Application Product in Data Processing)
- Knowledge Of Regulatory Affairs
- Created documentation templates for tracking inspection results, corrective actions taken.
- Performed root cause analysis investigations on defective products using statistical techniques such as SPC.
- Conducted quality assurance inspections of incoming materials and products to ensure compliance with established standards.
- Performed visual inspections of finished products.
Education
M Pharm( QA) -
Swaminarayan Sanskar Pharmacy College
Ahmedabad, India06.2016
Skills
- Practical knowledge of UV Spectrophotometer
- Dissolution apparatus, Sonicator, Centrifuge, HPLC
- Computer software knowledge of SAP, MS –Excel, MS-Word, Power Point
- Quality assurance
- Root cause analysis
- Regulatory compliance
- Process inspection
- Corrective actions
- Risk assessment
- Documentation creation
Certification
- Drug discovery and development
- Case processing in pharmacovigilance
- Adverse event and adverse drug reaction reporting
- Guideline and regulation (ICH - GCP)
- Clinical trial and phases
- General Pharmacology
- MedDra and WHO
- ICSR and SUSARs
Job Profile
Worked at Aculife Healthcare Pvt. Ltd. As an Officer in QA Department. (Duration June-2016 to Feb-2019).
Jobdescription
- Documentation
- Verify the BMR/BPR & QA/QC related documents like CCN, Deviation.
- Reviewed of entire batch record as per GMP and GDP norms and made it completed and corrected in all aspects.
- SAP (System Application Product in Data Processing)
- Preparation and Upload Inspection Plan and Analytical work sheet (AWS) of RM (Raw Material), PM (Packing Material), Bulk, SFG (Semi Finished Goods) and FG (Finished Goods) in SAP.
- Prepare and Upload Bill of Material in SAP system.
- Prepare and Upload BMR (Batch Manufacturing Record) and BPR (Batch Packing Record).
- Approved Quality Info Record in SAP System.
- In-Process Verification
- To certify line clearance during various processing stages.(Dispensing/Manufacturing /sampling/packing).
- Responsible for release of process order and documentation activities which includes BMR, BPR and formats from SAP.
Project Report
M.Pharm research Project “Development and Validation of Stability Indicating Assay Method for Estimation of Avanafil and Dapoxetine HCl in Pharmaceutical Dosage Form by RP-HPLC”
Areas Of Interest
Interested to work in Clinical Research and Pharmacovigilance, Corporate Quality Assurance, Quality Assurance (Quality Management System, Documentation) Department.
Personal Information
- Date of Birth: 4/8/1993
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that above stated particulars are true to the best of my knowledge and belief.
Timeline
QA Officer
Aculife Healthcare Pvt. Ltd.
06.2016 - 02.2019
- Drug discovery and development
- Case processing in pharmacovigilance
- Adverse event and adverse drug reaction reporting
- Guideline and regulation (ICH - GCP)
- Clinical trial and phases
- General Pharmacology
- MedDra and WHO
- ICSR and SUSARs
M Pharm( QA) -
Swaminarayan Sanskar Pharmacy College
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