AVANIBEN M PATEL
Edison
Summary
Result oriented Quality Assurance associate well experience in pharmaceutical industry including knowledge on Quality System documents, regulatory documents and CGMP documents.
Proven track record of success in administering quality systems and Expertise in improving quality systems.
Knowlegde of CGMP, GDP, GLP, QMS, CAPA, regulatory guidelines.
Strong training skills in CGMP and SOP’s.
Aspire to work with successful achievement in any given task to pursue my dream of becoming successful.
Overview
5
5
years of professional experience
Work History
Manufacturing Lead
Amneal Pharmaceuticals
03.2020 - 10.2022
- As a manufacturing Operator I am responsible for the batch-wise manufacture of Active pharmaceutical ingredients [API]. Utilizing batch logs, standard operating procedures [SOP], and work instructions under cGMP guidelines I would double check material calculations, check and prep process lines and equipment prior to start the batch. I have work up with hormonal product.
- Diagnosed issues quickly and contacted supervisor to warn of potential project delays.
- Modified controls to regulate production room temperature, pressure while monitoring outcomes and promoting successful processing.
- Followed all waste handling guidelines to minimize waste of product.
- Entered data into the batch records and checked information for accuracy.
- Followed safety processes and procedures.
- Maintained energy and enthusiasm in fast-paced environment.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Participated in continuous improvement by generating suggestions, engaging in problem solving activities to support teamwork.
- Well experienced with six months in Medical Lab Technician. Observed all tests which are performed in Biochemistry, Hematology and Microbiology department of Dr Krunal’s Laboratory in ANAND GUJARAT INDIA.
Quality Assurance Technician
RARITAN Pharmaceutical
02.2023 - 03.2023
- Carried out daily duties by filling room log books, weighing scales calibration, checking production rooms air pressure accurately and efficiently.
- Followed Master production batch records, Manufacturing formulas and following all CGMP’S and SOPS
- Weighing all incoming materials and outweighing materials as per the batch record while following CGMP’s and SOP’s.
- Maintains pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medicines and supplies; placing and expediting orders; removing outdates drugs.
- Completes/ reviews validation protocols, deviation reports, change controls in accordance with cGMP’s.
- Review SOP’s, batch records protocols and technical reports
- Handling/Completion of batch documentation.
- Maintain bacterial and mammalian cell cultures.
- Complete Batch Production Records under current Good Manufacturing Practices.
- Interface with Quality Assurance.
- Interact with Senior Management
- Experience with lab equipment : Chromatography systems, micropipettes, spectrophotometers, centrifuges, Ph meters balances.
- Responsible for the manufacture of therapeutic proteins (API; Active Pharmaceutical Ingredient) under good manufacturing practice (GMP’s)
- Dealing with batch records
- Labeling
- Giving line clearance
- Reviewing batch records
- Taking retention samples.
QA Stability Associate
Lupin Pharma INC
03.2024 - 05.2025
- To monitor temperature and humidity of stability chart recorders.
- Changing stability chart of all the chambers every week.
- To perform stability samples in-use study.
- Data entries using STSS [Stability ScienTek Software]
- Pulling and loading of stability samples into the required stability chamber.
- To submit stability samples to the QC lab for the scheduled stability testing/studies.
- Performing stability chamber reconciliation.
- Responsible for managing the stability testing programs, creating new files, input QC data and run trending reports.
- Responsible to ensure compliance with the procedure.
- Initiating all stability studies for commercial batches by issuing the stability study request form and submitting to floor QA for collection of stability samples.
- Scheduling the samples and placing them in appropriate stability chamber for required storage condition.
- Retrieving the samples at the appropriate due date and submitting the samples to the QC lab for testing.
- Monitoring stability areas/ovens/chambers for environmental and storage condition.
- Maintaining stability logbooks.
- Disposing stability samples from the chambers once the study is done.
- Also responsible for QA retains sample collection.
- Performing QA retains visual examination for customer complaints.
- Performing QA retains visual inspection for APR [Annual Product Review]
- Doing transactions into the SAP [System, Applications & Products]
- Approving QA reserve sample ID into the SAP.
Quality Assurance
Sanofi
05.2025
- Make sound decisions regarding packaging inspections, rework operations and final disposition of incoming materials according to Sanofi policies and procedures with minimum supervision.
- Strategically prioritize in-coming inspections to accommodate Manufacturing needs.
- Act as liaison with suppliers as necessary to resolve quality issues.
- Provide quality expertise and support to the Packaging and Manufacturing operations site. (Quality Oversight, logbook/AQL Inspection Forms review, solve issues in real time with Operations personnel, etc)
- Participate in process improvements to eliminate redundant inspections/sampling.
- Well versed in ANSI.ASQ Z1.4 sampling plans.
- Familiar with AQL sampling, normal, reduced, and tightened inspections and switching rules.
- Working knowledge of cGMP as it relates to inspection activities.
- Possess the ability to read and interpret component drawings and use measurement tools such as calipers and micrometers.
- Possess the ability to evaluate COA, Certificate of Analysis of chemicals/raw materials/packaging components.
- Collaborate with Purchasing Department and Suppliers to resolve in-coming inspection paperwork discrepancies and shipping issues.
- Possess strong organization, communication, writing, people skills/teamwork and detail oriented.
- Experience working in a team environment, facilitating a team approach, and communicating effectively.
- Practice safe work habits and adhere to Sanofi safety procedures and guidelines.
Education
Secondary School Certificate - undefined
Gujarat state education board
01.2012
Higher Secondary Certificate - undefined
Higher secondary education board
01.2015
Diploma - Medical Lab Technician
Bharat sevak samaj [online education]
Chennai01.2018
Skills
- Professional experience in Manufacturing under GMP protocol
- Policy implementation
- Strong attention to details
- Proven ability to prioritize and handle multiple tasks in a challenging environment
- Microsoft Office ( Excel, MS powerpoint, MS outlook MS word and etc)
- Database Management
- Excellent analytical, organizational and communication skills
- Articulate communicator with an appreciation for the different styles required when working with other team members or with customers
- Honest and Reliable: Able to take on tasks with a degree of responsibility due to strong morals and ethics ensuring honesty and reliability
- Time Management: Dedicated to effectively prioritizing and managing time by allocating tasks and activities and keeping track of them in diaries and daily to-do lists
- Good Communication: Able to communicate in English Hindi and Gujarati with team members or with customers
- Stability, Quality Control, Veeva, Documentum, SAP, Trackwise, CAPA management, Change Control, STARLIMS, and etc
Personal attributes
Well experienced with six months in Medical Lab Technician. Observed all tests which are performed in Biochemistry, Hematology and Microbiology department of Dr Krunal’s Laboratory in ANAND GUJARAT INDIA.
Personal Statement
I would describe me as an extrovert person with cheerful personality. I firmly believe in truth, honesty and hard work. I am reliable, honest and hardworking.
Timeline
Quality Assurance
Sanofi
05.2025
QA Stability Associate
Lupin Pharma INC
03.2024 - 05.2025
Quality Assurance Technician
RARITAN Pharmaceutical
02.2023 - 03.2023
Manufacturing Lead
Amneal Pharmaceuticals
03.2020 - 10.2022
Secondary School Certificate - undefined
Gujarat state education board
Higher Secondary Certificate - undefined
Higher secondary education board
Diploma - Medical Lab Technician
Bharat sevak samaj [online education]
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