Balaji SP

Experience

• 

  Bioniik

  Sept 2007 - Aug 2009

  Senior Executive
• 

  National Research Center for Banana

  Sept 2011 - Feb 2012

  Data Manager
• 

  Institute of Veterinary Preventive Medicine

  Feb 2012 - Aug 2012

  Senior Research Fellow

  Detection of Picornavirus infection (Foot & Mouth Disease) using ELISA technique Analyze the data for severity of infection. Submitting reports to Research Officer and presenting data in review meeting.

• 

  Sourz Foods India Pvt Ltd

  Sept 2012 - Apr 2014

  Manager Quality Assurance

  Quality Management, Quality Control, Quality Assurance, Audits, Quality reviews, Operational effectiveness. (Food Safety, CCP control and monitoring, Corrective actions, Internal audit and Documentation & verification. Supervision of Quality controls and its effectiveness. Conducting Management review meeting. Responsible for HACCP team. Attending customers Non confirmatory, mock recall and data entry of QC reports in to Microsoft Dynamics Navision (Business management software) and other official works then there assigning by the Management.) Show less

• 

  BellaPremier Happy HygieneCare Pvt. Ltd.

  May 2014 - Dec 2018

  Quality Manager

   QA Head for three production units -Medical Devices(ISO 13485 & CE), Nonwoven products( EN 13795), Feminine care product – Sanitary Napkins (BIS 5405) and one repacking unit of Imported hygienic products. Providing management and leadership to the quality team and lead inter- departmental quality strategies Certified ISO 13485 Internal Auditor - Oversee internal and supplier audit program, process and equipment validations Responsible to updating & maintain the documentations (Quality Manuals (GMP),TCF, Risk assessment) and implementation of international quality systems based on ISO 13485 & CE Assist in compliance to Medical Device Directive in the EU and thereby ensuring international product manufacturing compliance is established implemented and sustained Responsible to update new or revised regulatory requirements for the Class IIa medical devices Responsible as Management Representative and chair Management Review meetings Management representative responsible for ISO 13485 & CE periodic and recertification audits. Write and review quality and technical documents, quality procedures, reports andanalyze & interpret data. Control of raw materials & finished goods through Oracle (ERP) Liaison with Director of Drug Control Office, BIS and EU regulator bodies. Managing Lab Administrator, QC Microbiologist, Quality coordinator & Quality supervisors* Inspection of Surgical gloves manufacturing companies *Testing of Surgical Gloves Show less

• 

  KOB MEDICAL TEXTILES PRIVATE LIMITED

  Jan 2018 - Jul 2019

  Assistant Manager Regulatory & Quality Assurance

  Reported directly to the Deputy General Manager of Quality Assurance and Regulatory Affairs, ensuring a streamlined flow of vital information and insights.Synchronized seamlessly with certification body audits and customer audits, ensuring compliance and transparency.Assumed the mantle of educational stewardship, delivering comprehensive training to the workforce concerning ISO standards and regulatory mandates.Commissioned with the diligent aggregation of data, aligning with Key Performance Indicators (KPIs) from all operational processes, which was subsequently communicated to the Management Representative.Piloted the harmonization between the mother company KOB in Germany, ensuring the acquisition of all requisite technical documents vital for the unhindered passage of imported consignments through the Customs office.Held the mantle of Audit Manager and Internal Auditor, wielding authority over compliance with ISO 9001, ISO 13485, Indian Medical Device Rules, and the European Medical Device Directive (MDD 93/42/EEC)Curated the upkeep of the Company's Manufacturing license, Import License, Free Sale certificates and endorsements, Market Standing certificate, and Non-Conviction certificate.Established intricate liaisons with State Drug Authorities, the Central Drug Standard Control Organization in New Delhi, and the Bureau of Indian Standard (BIS) office.Championed the dissemination of dynamic regulatory changes to upper echelons of management, thus rendering them cognizant of evolving requirements.Entrusted with the oversight of a trading hub dedicated to the stocking and distribution of imported bandages.Championed the orchestration of corrective and preventive actions in response to Non-Conformities, fostering the continuous amelioration of operational excellence. Show less

• 

  Freelance (Self employed)

  Sept 2019 - Jun 2022

  Freelance -Appointment Setter & Closure -Medical Devices Regulatory Consultant

  Appointment Setting : Proficient in utilizing advanced outreach techniques and cutting-edge tools to secure valuable meetings with decision-makers. My strategic timing and personalized communication approach result in a high conversion rate from leads to confirmed appointments.Closing Excellence: Adept at employing consultative sales tactics to address objections, build trust, and close deals. My negotiation skills and persuasive finesse enable me to reach mutually beneficial agreements that align with clients' needs. Solution-Oriented Approach: Collaborative team player with the ability to gather insights from sales and marketing teams, ensuring alignment with market trends and creating compelling value propositions. Results-Driven Performance: I have contributed to significant revenue growth through meticulous pipeline management and strategic deal closure.Myself Skilled in engaging with diverse markets at global level and cultures, I bring a unique perspective that transcends geographical boundaries, unlocking opportunities on a global scale.If you're looking to amplify your sales efforts, enhance closure rates, and accelerate business success, let's connect! Reach out via LinkedIn messaging or email me ( [email protected] to explore how I can contribute to your company's growth story.Medical Devices Consultancy  Process compliance to ISO 13485, Indian MDR Validation & verification of process and product. Business facilitator for machine lines and Accessories sourcing , supplying & maintenance. Systemizing Operation & Quality system implementation for Personal Care production.  Sourcing RM & FG products MDR, CDSCO requirements and support to startups.  Process improvement and customized regulatory & tech solution to manufacturers. Show less

• 

  HCLTech

  Sept 2022 - now

  Technical Lead

  1) Team lead responsible to reporting to Project Manager.2) Managing MDR team of 10 members.3) Everyday work allocation to team members – MDR, Supplement MDR, DT post investigation, DT approvals.4) Ensure the team members are timely completing the work. 5) Updating to client on weekly basis about MDR completion and status. 6) Root cause analysis on late MDR and reporting to client.7) Responsible for Supplier Corrective and preventive action report.8) Conducting MDR rejection meeting with MDR team members, to discuss and improve the quality of work.9) Other work: Feedback and give score to team members on their performance. Team members attendance & leave approvals. Show less