Vileshkumar Patel

* **** **, **** -*, Lake Hiawatha, New Jersey 07034

Contact No: (M) 347-***-****

Email ID: ad2r2c@r.postjobfree.com

Career Objectives:

• To work in a challenging environment successfully without compromising on quality with work in pharmaceutical field.

• Apart from a passion to lead a successful, contented professional life, I would like to venture on challenges and opportunities for excellent, professional, and personal growth in leading pharmaceutical companies and to grow with the company. Summary of Qualifications:

• Familiar with compliance requirements within cGMP, safety, and regulatory environments.

• Responsible for managing workloads using a priority-based approach.

• Able to perform the duties assigned complying with the objectives of the company. Work Experiences:

Amneal Pharmaceuticals. New jersey USA. July.2022 to Present Quality Assurance Inspector II

Responsibilities include inspecting, testing, sampling, and sorting products or goods being manufactured. This ensures that the shipped product fulfills all customer specifications and quality requirements. The manufactured products can include a large range of items such as medicine, machinery, equipment, and pharmaceuticals.

• Provide analytical testing support for release, stability, validation, and in-process samples.

• Support GMP manufacturing through tech transfer, training, and master batch record generation and review.

• Follow the protocols for the Stability and PPQP Batches.

• Having experience in the Control Drug Operations and Packaging.

• Perform Rinse and Swab Sampling for microbial cleaning verification.

• Enforcing cGMP guidelines for manufacturing and packaging of Pharmaceutical Products

• Perform room, Equipment, and packaging line clearance prior to each stage of manufacturing following detailed written procedures.

• Responsible for inspecting the product and components being packaged for accuracy.

• Responsible for performing necessary testing on product being inspected (Vacuum Leak Test, Weight variation, Torque Testing, Label Challenge Test, Vision Challenge Test, Barcode Scan, etc...)

• Responsible for generating and documenting all work performed daily.

• Responsible for generating and collecting all paperwork to retain samples collected (in-house, QA, sales, and customer)

• Pull out samples from the manufacturing / Packaging Process as required per batch records and / or established protocols and submit them to the QC Lab.

• Perform Inspection and sampling of all incoming Raw Materials, Packaging Components and Returned goods following detailed written procedures.

• Perform Labelling Component receipt, Visual examination, Counting, Preliminary inspection and sampling.

• Visual Inspection and Preparation of report on all Products of APR

• Inspected Product during and after Manufacturing.

• Examined Products and Materials for defects or deviations to remove or discard non-conforming items.

• Adhered to safety Protocols to minimize equipment damage and avoid injuries.

• Documented Inspection Result by completing reports and logs and summarizing and entering data into quality database.

• Consulted with engineers to resolve quality, Production, and efficiency problems.

• Oversaw proper tagging and identification of parts and components, enabling rejected or non- repairable parts to be properly marked, quarantined, and rendered unusable.

• Perform manufacture bulk sampling.

• Perform Environmental Monitoring for Microbial Examination.

• Knowledge about JDE Software (for the Stock Inventories) SOXA Formulations and Research Ltd Jun.2020 – Feb.2022 Quality Assurance

• Develop and execute test plans to ensure that all objectives are met.

• Implement and monitor test Scripts to assess functionality, reliability, performance, and quality of the product.

• Identify and remedy defects within the production process.

• Perform testing according to approved SOP and methods and report data.

• Perform independent technical review of documentation.

• Author technical reports and protocols and review data.

• Plan work accordingly to meet production and schedule requirements.

• Provide mentorship to junior scientists.

• Train Inters and Students for safely handling Laboratory instruments and general laboratory procedures.

Hester Biosciences Ltd. Jan.2019 – Jun .2020.

Production Officer

• Perform Sampling under LAF.

• Support development of robust, scalable, and high productivity cell culture processes for large scale production.

• Experience in doing manual handling for Inoculation,

• Manual Fluid based Harvesting from Duck eggs and Hen eggs.

• Support GMP manufacturing through tech transfer, training, and master batch record generation and review.

• Write technical reports that go into CMC sections of IND.

• Prepare, sterilize, and organize supplies for various routine operations.

• Discuss the work plan with the supervisor and carry out the work according to the plan.

• Regularly note the experiments in electronic notebook and discuss with the supervisor.

• Having strong organizational skills and being efficient with minimal supervision.

• Provide training for Interns and Junior scientists.

• Large-Incubator Monitoring

• Aseptic handling

Pellucid Lifesciences Pvt. Ltd. Nov.2017 - Jan.2019. Production Executive

• Manage the operation of small (150 L), large scale (15 KL) fermenters at pilot and production scale as required.

• Author and review various technical documents like batch manufacturing record, sampling, cleaning etc.

• Experience with lab scale and production scale reactors.

• Perform analytical and microbiological testing like pH measurement, fermentation, serial dilution as required.

• Perform Up-steam And Downstream Process,

• Perform Inoculation,

• Perform Sterilization,

• Routinely prepare media and various buffers for various day-to-day activities,

• Maintain stock records of reagents, chemicals, etc.

• Routinely perform pH and temperature monitoring.

• Capable of handling automation software like SCADA,

• Experience in operating, monitoring, and cleaning of Spray Dryer.

• Routinely perform Raw material Sampling

• Perform Blending

• Operate various centrifuges and filtration processes as required.

• Highly flexible with working in a team environment and rotating production schedules.

• Good problem-solving skills.

Education:

• Master’s in biotechnology 2012 - 2014

Kadi Serva Vishwavidyalaya University, India

• Bachelor’s in biotechnology 2009 – 2012

Hemchandracharya North Gujarat University, India

Contact this candidate