Shru************

Quality Management Specialist with special focus in Analytical, Deviation and Change Management.

  • 560100 bangalore India 
  • Graduation: M.Sc in Biochemistry and MBA in Pharmaceutical Management

  • Hourly / Daily / Monthly Rates: 150 / hour 1200 / daily 24000 / monthly

  • Languages: English(Full Professional) | Hindi(Full Professional)

  • Last Update: 01.11.2019 at 08:46

Job Type
Part Time
Availability
Not Available
Place
bangalore
Country
India

Category :

Regulatory, Quality and Clinical

   

Keywords :

  

Key Account Manager


Skills

PROFILE SUMMARY

Result-oriented professional having 13 years’ experience in QC and QA in Biopharmaceutical and Pharmaceutical Industry. • Technically skilled in Quality Management System procedures and in Trackwise system, SOP preparations, Document management & Harmonization of procedures. • Well-versed with analytical techniques essential in testing of raw material, finished product and stability samples of API and Formulation, including hands-on experience in HPLC- RPHPLC, size exclusion, CIEX, UV-Vis & AAS. • Expert in establishing specification for Inhouse developed products by evaluation of reference product as part of Biosimilar product development. • Expert in training management including design of training module suitable for employee training under Bizapp software program. • Self-motivated & collaborative, known for leading & mentoring team allied in multidisciplinary cross-functional activities to ensure efficiency in QMS operation and due deliverables within the agreed timelines. • Good at communicating at all levels & functions effectively whether individually or as a team. • Expert in coordination with Company Partners (Viatris and Global stakeholders) and Global Customers (BIVI, Baxter, Celerity, Thermo fisher, FFTC, Labpisa, Getz, Sedico, Incepta, Farmak, PHS, Sothema, etc.) for receival of approvals for changes and to support RA teams in filing annual changes with agencies.

PROFESSIONAL ACCOMPLISHMENTS:

• Managed Quality Compliance functions in following areas: QMS (APQR, Change control, Document Management, CAPA, Investigation OOS/T, Deviation, Self-inspection, Customer complaints, Customer and Regulatory compliance, Training, GxP documentation), validation & Qualification (CSV, Method, Instrument & Equipment). • Worked on major change controls for Upstream Manufacturing Plant Expansion, New QC RM lab set up, Freeze Dryer replacement used for API processing at downstream manufacturing, Harmonization of Empower HPLC system implementation across QC labs, Scale upgradation of in house manufactured critical raw material and further its usage in drug substance manufacturing and changes with respect to cell banks. • Handled preparation of SLIA and Risk assessment involving relevant stakeholders for successful Implementation of changes. • Contributed for product launch program at different regulated markets headed by partner company w.r.t Change controls. • Handled OOS and Deviation investigations from different functional areas like testing, manufacturing, E&M, facility, and raw materials (extending investigations at vendor site). • Handled analytical instruments like HPLC, UV spectrophotometer, GC, KF titrator, flame photometer, AAS, polarimeter, viscometer, etc and Calibration. • Well versed with trouble shooting of HPLC instrument. • Managed weekly review of computer system-based instruments data for Data integrity and Audit trail. • Managed analytical testing compliance with national and international testing standard for pharmaceuticals • Worked on writing stability protocols, maintain stability chambers/programs, review/manage stability reports. • Managed specification setting for developing biosimilar product through reference product analysis. Performed forced degradation study by Head-on-Head comparison between Inhouse and reference product as part of Biosimilar product development. • Performed In use study to check impact of increase in head space in formulation vials during regular usage. • Developed training module suitable for employee training under Bizapp software program. • Designed data base module using Microsoft excel program best suitable for tracking and trending of QMS elements. • Handled APR preparation for multiple products by review of laboratory, process, qualification, QMS and material management aspects. • Managed Batch Release by ensuring closure of all associated QMS elements and by receiving clearance from customers in line with quality agreement. • Handled In process and finished product quality parameter trending on Minitab for tracking OOT and OOCT. • Performed Gap Analysis to ensure system compliance to face regulatory audits. • Contributed to Internal and External Audits/Regulatory audits like US FDA, EMEA, PMDA, TGA, Health Canada, COFEPRIS (Mexican MOH), Korea MOH and Iran MOH.


Refrences

• Working from Aug’ 2008  to Aug 2021 at Biocon, Bangalore,  as Deputy manager leading Quality Management System team.

• QC chemist, Group Pharma Ltd, Malur, from Sep’ 2006 – June’ 2008.

• Worked in Biosimilarity project in establishing specification for Inhouse product  throgh head on head analytical assessment of Innovator product.

• Worked for new QC lab set up from to end for Raw material and Packing material Analysis.

• Worked in upstream facility refurbishment project from end to end till receival of approval for changes from multiple customers supporting them in filing this change from QMS end.

Worked for key project involving company name change, associated document revisions and operating under hybrid system till full fledged implementation of this change.

•  Worked for key OOS investigation invoving extended investigation at vendor site for critical raw materials.

• Worked for trackwise digital system implementation for handling  Quality management system parameters.

• Contributed in key regulatory audits like US FDA, EMA, TGA, PMDA, etc.


Time and Spatial Flexiblity

Travelling is acceptable

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