Sivaiah B Email and Phone Number
Total 15.0 years of experience in pharmaceutical industry in QA & QC departments.Key skills: • CSV project specialist in compliance with GXP Assessment/CSV Assessment GAMP5,EU Annex- 11 compliance requirement,Risk based approach & Data integrity compliance as per 21CFR regulatory requirement part 11.• Equipment’s/ Instruments Qualifications.• Participation of internal Audits.• Knowledge on regulatory guidelines such as ICH, 21 CFR (part 210 and 211), MHRA, FDA, WHO, etc.• Batch release activities.• Certified QMS investigator from Quali Culture Consulting Group. • SME Expert in Process & QC QMS Investigations (OOS/Deviations/Customer complaints/Incidents)• Certified QMS investigator from Quali Culture Consulting Group. Previous worked companies:• Cipla • Aurobindo Pharmaceutical Ltd (Formulation)• Microlabs Ltd (Formulation)• Piramal Healthcare Ltd• Dr. Reddy’s Laboratory Ltd
Syngene International Limited
View- Website:
- syngeneintl.com
- Employees:
- 4146
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Assistant ManagerSyngene International Limited Oct 2017 - PresentBangalore Urban, Karnataka, IndiaCorporate Quality Assurance, having 15 years of experience in Quality Assurance and Quality control. Worked in Pharma and Biopharmaceutical companies. Hanads on experience in Quality Management System, Investigations, Audit & compliance and Analytical Quality Assurance.Well worse with FDA 21 CFR part 210 and 211, ICH, MHRA, CDSCO and other guideline requirements and compliance.
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Management StaffCipla Mar 2015 - Oct 2017Bangalore Urban, Karnataka, IndiaAnalytical Quality Assurance, QMS and investigations -
Senior Qc AnalystAurobindo Pharma Ltd Oct 2013 - Mar 2015IndiaReview of the laboratory test reports (RM/PM/API/Stability/Non-Routine).Participating QMS investigations.Assist Unit Quality assurance in handling of materials/product complaints. -
Quality Control AnalystMicro Labs Limited Apr 2011 - Oct 2013Goa, IndiaPerforming finished product/API/Stability/Raw material analysis of as per specification.Performing method validation/method transfer analysis.Supporting to non-conformance investigation.Fallowing cGMP/cGLP guidelines.
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Quality Control AnalystPiramal Healthcare Limited Apr 2010 - Mar 2011Chennai, Tamil Nadu, IndiaPerforming finished product/API/Stability/Raw material analysis of as per specification.Performing method validation/method transfer analysis.Supporting to non-conformance investigation.Fallowing cGMP/cGLP guidelines. Hands-on knowledge of principles and operation of analytical equipment such as HPLC, GC, Dissolution, PSD, Spectrophotometers (UV / FT-IR), Polarimeter, Karl Fischer titration with various software’s i.e. Empower/ Chromelon/LC Solution/Master Sizer/ Tiamo, etc.
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Quality Control AnalystDr. Reddy'S Laboratories Jun 2008 - Apr 2010Hyderabad, Telangana, IndiaPerforming finished product/API/Stability/Raw material analysis of as per specification.Performing method validation/method transfer analysis.Supporting to non-conformance investigation.Fallowing cGMP/cGLP guidelines. Hands-on knowledge of principles and operation of analytical equipment such as HPLC, GC, Dissolution, PSD, Spectrophotometers (UV / FT-IR), Polarimeter, Karl Fischer titration with various software’s i.e. Empower/ Chromelon/LC Solution/Master Sizer/ Tiamo, etc.
Sivaiah B Education Details
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Biotechnology
Frequently Asked Questions about Sivaiah B
What company does Sivaiah B work for?
Sivaiah B works for Syngene International Limited
What is Sivaiah B's role at the current company?
Sivaiah B's current role is Associate Manager (CQA) in Syngene International Limited. SME in CSV/Equipment Qualifications/Process & Analytical Investigations/ & Batch Release Activities..
What schools did Sivaiah B attend?
Sivaiah B attended Periyar University.
Who are Sivaiah B's colleagues?
Sivaiah B's colleagues are Lingaraju Siddappa, Nataraja Moorthi, Shadakshari P, Latha K N, Priya Raichur, Rohit Zambare, Vigneshwaran Paulraj.
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