SAICHARAN MADUPATHI
Tuniki
Summary
- A hard working ,motivated individual with excellent communication Skills.
- Very organized with strong attention to details and time management .
- Energetic team player ,who takes pride in quality of work looking for an opportunity to begin a new career while contributing to the success of the business.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Officer
Gland Pharma Limited
Hyderabad
01.2019 - Current
- Company Overview: Pharmaceutical industry specializing in sterile injectable products
- In-process quality check activities according to SOP in production / packaging departments (Tablets/Capsules/liquids/Semi solids/Injectable) in complying with cGMP principles and captures test results in batch records
- Check the required tests for all products during production / packaging process
- Inspection and check incoming materials by confirming specifications and return unacceptable materials
- Revise all documents for in process control and perform a quality review of logbooks
- Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system
- Internal Audit programs
- Preparation of Annual Product Quality Review reports
- Responsible for Deviations and Market Complaint investigations and ensure implementation of CAPA lifecycle
- Ensure the in-process check equipment’s are adequately calibrated and functions properly
- Perform and check the line before start (production/packaging) and give the clearance for the work
- Maintain accurate records and perform tests on all activities conducted in the plant
- Maintain safe and healthy work environment by following standards and procedures and complying with regulations
- Perform Self-inspection runs in his areas
- Line clearance
- CCIT of sample checking
- BPCR review
- Documents review as per GMP and GDP
- Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records
- Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories
- Responsible for cleanliness, calibrations and any malfunction to be reported on time to line manager
- Maintain a logbooks and test results are record in documents
- Pharmaceutical industry specializing in sterile injectable products
Education
Msc - global public health
University of essex
Colchester01.2023
Bachelor of Pharmacy -
Gland Institute of Pharmaceutical Sciences
01.2018
Intermediate -
Vaishnavi junior College
01.2014
SSC -
Nalanda High School
01.2011
Skills
- PHARMACOVILANCE SKILLS
- Good knowledge on ICH-GCP,GVP modules
- Basic knowledge on argus safety data base
- Knowledge on data capturing and management activities
- Phases of clinical trials
- Regulatory authorities, submission timelines
Certification
- Secured 3 prizes for sports in college sports tournament.
- Participated and presented POSTER PRESENTATION in TIN–PNW-2016 held at JNTUH.
- Presented a paper in AUSHAD2k17 at Vishnav Institute of Pharmaceutical Sciences.
- Volunteer and organized university Fest’s.
Languages
- English
- Telugu
Hobbies and Interests
- Listening to Music
- Sports
Projects
Microwave Assisted Synthesis and Antimicrobial Activity of Novel Thiazolidinone and Azetidianone Derivatives
Disclaimer
I hereby declare that the above mentioned information is true in the best of my knowledge.
Personal Information
- Date of Birth: 01/16/96
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
Place
Tuniki, Narsapur, Telangana, India
Languages
English
Proficient
C2
Timeline
Quality Assurance Officer
Gland Pharma Limited
01.2019 - Current
Msc - global public health
University of essex
Bachelor of Pharmacy -
Gland Institute of Pharmaceutical Sciences
Intermediate -
Vaishnavi junior College
SSC -
Nalanda High School