SAI SEKHAR SIDDI
HYDERABAD
Summary
Dynamic Manufacturing Chemist and Quality assurance Executive with a proven track record at HIMAJA RENAL CARE PRODUCTS, excelling in formulation development and lean manufacturing processes. Spearheaded Initiatives that significantly reduced waste and enhanced product consistency through rigorous process validation and environmental monitoring. Known for exceptional problem-solving abilities and fostering a culture of safety and continuous improvement.
Overview
13
13
years of professional experience
Work History
Quality Assurance Executive
HIMAJA RENAL CARE PRODUCTION
HYDERABAD
05.2018 - Current
- Preparation and execution of process validation (PV) protocol (prospective, retrospective, and concurrent). Batches protocol for products, (sampling, physical analysis of samples, and execution and completion of PV reports, etc.).
- Involve executing cleaning validation activities.
- Review of Batch Manufacturing Record (BMR).
- Review of Masters Document (MBMR).
- Randomly checking various Mfg. Packing documents.
- Line Clearance and Monitoring Product Changeover at Various Mfg. Packing operation.
- Raising incident reports and monitoring investigations, whenever required.
- Handling of Change Control.
- Participation in various training organized is planned.
- Final Finished Product Inspection.
- Review of SOPs, STPs and other documents, whenever required, QA.
- Developed and implemented quality assurance policies, procedures, and processes to ensure product compliance with established standards.
- Compiled reports by reviewing records and documentation.
- Created, edited, and updated project manuals and technical documentation used by entire QA team.
- Reviewed manufacturing documentation, including specifications and instructions. for accuracy and completeness.
- Supervised and guided inspectors, technicians, and other staff.
- Analyzed quality control data to identify trends, root causes of issues, and areas for improvement in processes and product quality.
- Performed audits of supplier quality systems to ensure compliance with applicable regulations and standards.
Manufacturing Chemist
Himaja Renal Care Products
Hyderabad
03.2012 - 04.2018
- Production planning and scheduling with material and manpower requirements.
- Reporting and reviewing of daily production and respect to product, equipment's, material and operation.
- Monitored production operations to ensure compliance with safety regulations and quality standards.
- Provided technical support on process validation activities, such as cleaning validations, equipment qualifications, and process validations.
- Implemented methods for tracking and analyzing data to identify trends in product performance, or yield losses.
- Evaluated existing manufacturing processes for potential improvements.
- Ensured that all batches are produced in accordance with approved protocols and specifications.
- Created plans to improve operational efficiencies while maintaining product quality standards.
- Assisted in troubleshooting complex problems related to manufacturing processes or equipment malfunctions.
- Made decisions and executed changes based on process data, quality checks, and test results to keep products at target and within specifications.
Education
Master of Pharmacy - Pharmaceutical Management and Regulatory Affairs
KVK COLLEGE OF PHARMACY, JNTU-HYDERABAD
HYDERABADBachelor of Pharmacy -
SAFA COLLEGE OF PHARMACY ,JNTU-ANANTHAPUR
KURNOOLBoard Of Intermediate Education A.P -
P M R JUNIOR COLLEGE
NANDYALSecondary School Certificate -
SRISAILAM PROJECT HIGH SCHOOL
SRISAILAM DAM EASTSkills
- Records management
- Recordkeeping requirements
- Data interpretation
- Product Development
- Technical Presentations
- Data Management
- Hazardous waste management
- Batch record analysis
- Quality management system
- Documentation review
- Quality assurance executive skills,
- Quality assurance experience
- QA documentation
- Quality assurance guidance
- QA reporting
- Internal audits
- Product testing
- Lean Manufacturing Processes
- Formulation Development
Strength
- Responsibility
- Adaptability
- Analytical thinking
- Flexibility
- Communication
- Confidence
Technical skills
- MS Word
- MS Excel
- power point
Personal Details
- Date Of Birth / Age : 19/06/1986
- Marital Status : Married
- Nationality : Indian
Languages
Telugu
First Language
English
Intermediate (B1)
B1
Hindi
Beginner
A1
Interested Of Area Work
- Regulatory affairs
- Quality Assurance
- Production
Timeline
Quality Assurance Executive
HIMAJA RENAL CARE PRODUCTION
05.2018 - Current
Manufacturing Chemist
Himaja Renal Care Products
03.2012 - 04.2018
Master of Pharmacy - Pharmaceutical Management and Regulatory Affairs
KVK COLLEGE OF PHARMACY, JNTU-HYDERABAD
Bachelor of Pharmacy -
SAFA COLLEGE OF PHARMACY ,JNTU-ANANTHAPUR
Board Of Intermediate Education A.P -
P M R JUNIOR COLLEGE
Secondary School Certificate -
SRISAILAM PROJECT HIGH SCHOOL
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