Hemal Patel

Experience

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  Alembic Pharmaceuticals Limited

  Sept 1990 - Jul 2003

  Senior Microbiologist and Production Assistant

  • Skilled in manufacturing of sterile bulk drug (API-Penicillin) as per BP, USP, and internal requirements (by Extraction, precipitation, sterile filtration, reaction, draining, vacuum drying and vacuum distillation.)• Maintained sterile environment by settling plates, air sterility flask, positive air pressure, temperature, percentage related humidity and by spraying and mopping of different disinfectant.• Ensured aseptic condition during process operation and final packing of sterile products. • Analyzed data from drug development and validation studies and performed investigations on study non-conformances and process variability.• Created drug development and validation reports from study data.• Implemented and achieved highest standard of relevant SOP, cGMP, ISO and Safety guidelines at all the stages of manufacturing.• Supervised washing and sanitization of product contact parts for filling equipments.• Prepared and maintained schedule for calibration of equipments. • Experienced in the renovation and upgradation of two sterile plants as per cGMP norms• Operated different types of sterilizers such as Autoclave, Dry heat sterilizer and Moist heat sterilizer. • Involved in packaging of sterile and non sterile final products. • Organized production and planning as per consumer demand. • Prepared and executed process and equipment validation plan as per cGMP• Executed data created for MRP (material resource planning) in SAP.• Modified sterilization procedures based on isolated microorganisms during microbiological testing of sterile areas as needed.• Performed air sampling, swab test, personal monitoring test and particulate count for checking sterility in sterile area.• Conducted microbiological tests to detect Endotoxins and Pyrogens in water.• Validated the performance of sterilization equipment such as M.H.S., D.H.S., Autoclave, A.H.U. and L.A.F.• Prepared, wrote and reviewed process documentation (ex. SOP, WI, Documentation). Show less

• 

  Apotex Inc.

  May 2004 - Aug 2004

  Production Technician

  • Filled, labeled and inspected liquid dosage forms of medications• Performed sanitation of packing and manufacturing equipments as per SOP.• Performed the blister packaging procedure and performed related in-process tests such as leak test.

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  GSK

  Oct 2004 - Feb 2005

  Technical Team Member

  • Involved in the organization and primary/secondary specialty packaging of medications.• Responsible for inspecting Line Clearance at the beginning and end of the batch to maintain quality and accuracy.

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  Teva Pharmaceuticals

  Feb 2005 - now

  • Performing audits and release of bulk executed manufacturing documentation by ensuring GMP and SOP compliance.• Performing timely reviews of work orders ensuring appropriate steps/actions have been taken and documented.• Working as QAF to evaluate quality incident, BAS incident and PSS .• Creating CAPA and QA protocol.• Leading and working collaboratively with site operations in the resolution of quality incidents and deviations by completing the DIF and determining product impact assessment to ensure compliance with GMPs and SOPs.• Preparing a daily quality shift report.• Performing additional documentation audits/reviews and internal plant GMP audits such as logbook auditing, Acceptance Quality Limit (AQL) inspections and evaluations.• Leading the communication and coordinating with various departments to obtain necessary information/documentation required for product review/release to meet schedule. Show less • Auditing and reviewing manufacturing documents on a weekly basis. • Operating and troubleshooting printing, capsulation and compressed tablet machines.• Executing processes in compliance with related SOPs and GMP standards.• Performing machine change over, cleaning and set up as required.• Ensuring adherence to quality standards during all stage of the manufacturing process.• Performing AQL as issued by QA for investigating quality issues.• Involved in updating manufacturing documents and SOP.• Cooperated with team members in A3 problem solving and Continuous Improvement template to resolve quality related issues. Show less

  • Quality Assurance Specialist

    Apr 2020 - now

  • Process Operator -2

    Feb 2005 - Apr 2020
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  Metro College of Technology Pty. Ltd.

  Aug 2009 - Oct 2010

  Co-op programmer

   Successfully completed SAS Project on Customer Relationship Management (CRM)  SAS experience including: BASE, MACRO, SQL, and GRAPH. Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset. Experience in creating and maintaining a SAS macro-based clinical reporting system to generate clinical trial tables, listings and graphs. Competent with computer software packages (i.e. proficient in Microsoft Office applications, Internet, and relational databases). Demonstrated effective organizational and time-management skills. Ability to manage multiple priorities in an efficient manner. Demonstrated ability to work independently and as part of a team.  Establish the SAS programming needs for a project and develops work-plan to deliver SAS outputs for Data Management. Merges datasets, as required for Integrated Summaries. Writes, validates and maintains SAS programs and macros to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trial data. Assists in any SAS activities needed to ensure timely database lock (e.g. producing listings for review of data, quality control checks or blinded analyses dataset creation). Transforms various formats received from both internal and external clients into SAS datasets and transport files. Builds and maintains a library of SAS codes and outputs submitted to internal and external clients. Show less

• 

  Amgen

  Jan 2013 - Jan 2016

  SAS Programmer

  • Accessing, managing, and transforming clinical trials data, such as importing data. SAS/ACCESS LIBNAME statement, calculating change from baseline, deriving LOCF variables. • Reporting clinical trials results, such as creating listing, table and graphs with statistical procedures and macro program.• Implementing the CDISC SDTM and ADaM with Base SAS; and building Define.xml with Base SAS. • Importing and exporting raw data files.• Manipulating and transforming data.• Combining SAS data sets.• Creating basic detail and summary reports using SAS procedures.• Identifying and correcting data, syntax and programming logic errors.• Validating and cleansing Clinical Trial data using Statistical procedures. Show less