Srinivas Parimi PhD

Experience

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  IanWark Research Institute, University of South Australia

  Mar 2006 - Aug 2010

  Research Scholar

  Research - Performed research activities involving planning, execution and analysis of the work.- Focussed research efforts to optimize nanoparticles for their effective delivery as drug vehicles- Area of research focussed on identifying mechanistic and kinetic aspects of dendrimers at the lipid bilayer interface.Communication skills (Oral and Written)- Published 2 peer-reviewed research articles in A* journals (Langmuir and Biomacromolecules). - Presented seminars at various national conferences. Show less

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  Hospira

  Jun 2011 - Oct 2013

  Scientist - Biologics Research and Development

  Client and Company Focus- Supported both Hospira's internal biosimilar portfolio and proprietary third party One2One Bioservices contracts. Downstream Process Development- Developed purification processes at small to pilot scale for use in commercial scale GMP operation. - Independently with occasional support from manager designed experiments, collected and analysed/interpreted information and produced in accordance with the project timelines and contract deliverables.Communication (Oral and Written)- Wrote client as well as internal project reports- Also revised various standard operating procedures (SOPs) for implementation within the facilitySupport and Assistance- Supported Quality Assurance department as well as Research and Development department in initiating and closing out change control procedures. - Handled the deviations from various procedural updates. Show less

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  Real Staffing contracting to Eris Pharmaceuticals (Australia) Pty Ltd

  Aug 2014 - Dec 2014

  Quality Assurance Officer

  Legislative- Maintained the Quality Management System (QMS) and quality related improvement initiatives in compliance to the TGA guidelines.Review & Release Quality Documents- Reviewed batch manufacturing (BM) and batch packaging (BP) records received from the contract manufacturer.- Annual Product Quality Reviews (APQRs) were performed on products and updated the approved supplier/manufacturer qualification status. Management of deviations/non conformances - Identified non- conformances in the manufactured and packaged batch records;- Managed the deviations within the production processes and ensured their closure in time. Release of products for sale- Upon approval of various manufacturing batches in compliance to the quality specifications, released products for their sale to various Australian and International markets;- Transcribed/Generated certificate of analysis (CoA) prior to their release to the market. Documentation- Prepared various internal quality documents- Maintained the change controls and employee training records- Created internal audit schedules Show less

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  Omniblend

  May 2015 - Jun 2015

  Quality Assurance/Quality Control Support

  Quality Control/Quality Assurance- Performed quality control testing of high protein shakes, energy drinks and other long life drinks.- Documented the test results and submit for approval prior to the release of individual batches.

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  Hospira, A Pfizer Company

  Jun 2015 - Feb 2016

  Quality Assurance Associate, Manufacturing Quality

  Review and Release of Products:- Performed annual product quality reviews (APQRs) of various US finished products and products of Asia-Pacific region.- Conduct retention reviews of finished products and update the internal inventory system with the status of the stored products;Auditing- Performed internal auditing of facilities ensuring compliance with FDA/TGA international regulatory standards.- Conducted inspection audits of batch manufacturing process within the facility. Show less

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  On Q Recruitment

  Feb 2016 - Apr 2016

  TGA Assessor APS 5

  Review and approve good manufacturing practices (GMP) Clearance applications for MRA regulated countries.

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  Ixom Operations Pty Ltd

  Jan 2017 - Oct 2017

  QA//RA Officer

  • Support Quality Assurance/Regulatory and Customer Service teams in updating unrestricting batches, updating specifications/CoFAs, permits, quality documents whilst maintaining supplier information using SAP and associated databases; • Liaise with internal and external stakeholders ensuring customer complaints, batch release and document maintenance activities are performed in a timely manner;• Perform planning, scheduling and testing of fragrances for various formulations whilst ensuring their conformity with International fragrance standards (IFRA code of Practice). • Perform internal GMP and housekeeping audits, updating HALAL and Kosher certifications for in-house flavor products. Show less

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  PharmaCare Laboratories

  Oct 2017 - now

  Lead various registration projects across Rest of Asia Pacific markets whilst guiding team and consultants for successful completion of projects.Supporting registration dossier preparations for submission as low risk drugs in few ASEAN markets.Support and lead team whilst guiding on various NPD projects and other regulatory activities. Oversight on the managerial responsibilities of various Rest of Asia countries whilst supporting the team as well as country managers ensuring successful product registrations in the respective countries;Support the customs clearance process for various shipment products as well as ensure provide technical support or advise about various products to the country managers. Help registration of various PharmaCare's products across most of the Asia Pacific countries. Support the development and training of employees on various internal procedures and products whilst ensuring the company's international market reputation is increased. Liaise with internal and external stakeholders of various countries. Support the company's registration activities in various Asian markets.

  • Senior Manager Regulatory Affairs

    Aug 2023 - now

  • Regulatory Affairs Manager

    May 2019 - Aug 2023

  • Senior Regulatory Affairs Associate

    Apr 2018 - Apr 2019

  • Regulatory Affairs Associate

    Oct 2017 - Apr 2018