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CRQA Team
CRQA GMP AUDITOR
Over nineteen years of experience in Quality and technical operations of pharmaceutical formulations like tablets, liquid dosage, soft gel capsules, capsules, herbal medicine, herbal cosmetics, pharmaceutical APIs and medical device. Skilled in decision making, selection of optimistic approach and negotiation for the implementations of the decision, strong inter personal skill and result oriented and as a Quality Conscious Personality. Well versed with cGMP/GLP regulations for API’s and dosage forms. Hands-on with USFDA, MHRA, TGA, HSA, Gulf FDA and ISO requirements and audits designing, validation, setup, technology transfer and start-up of new pharma facility. Expert in internal, vendor and third party audits in compliance with cGMP and ISO standards.
GCP / GMP / GLP Auditor
Has rich experience of 20+ years in pharmaceutical industry / institutes; this includes 15+ years of QA experience in Dr. Reddy’s Laboratories; Jubilant Clinsys & Dabur Research Foundation. An approved analytical chemist from Uttar Pradesh Drug Authority; registered QA personnel from SQA; and also trained Pharmacovigilance personnel – by Indian Pharmacopoeia Commission; Ministry of Health and Family Welfare, Govt. of India. Experience includes QA of all stages of Drug Lifecycle - GMP, GLP & GCP.
As QA personnel has been involved in:
  • Conducting Audits – Internal and External audits, Planning and Facilitating sponsor audits, Regulatory Inspections etc.
  • Developing and Reviewing SOPs
  • Conducting Training sessions
  • Designing and setting of QA systems
Wide range of Clinical QA Experience includes:
  • Investigator Site Audits
  • System Audits: Investigational product storage and distribution; Archiving etc.
  • Phase I-IV clinical trials; Bioavailability (BA/BE), preclinical audits
  • Facility Audits (GCP & GLP)
  • TMF Audit
  • Database Audit
  • TLG Audit
  • Vendor Audits
  • Sponsor Audits
  • Regulatory Audits
  • IB review; CTD review; SP review
  • CSR Audit
GCP, Pharmacovigilance, GLP & GMP Auditor
  • Professional with over 18 years’ global experience in pharmaceutical industry in Quality assurance of Pharmacovigilance, Clinical trials (Phase I-IV, BA/BE), New Chemical entity, GLP and GMP area.
  • Expertise in conducting Affiliate, Sponsor, Contract research organization, business partners, Clinical sites and Service provider audits in almost all geographic locations e.g., USA, UK, Germany, France, Italy, Sweden, Ireland, Switzerland, Africa, Thailand, Vietnam, Israel, etc.
  • Phase I-IV clinical trials; Bioavailability (BA/BE), preclinical audits
  • Successfully established Global Pharmacovigilance Quality Assurance and Clinical Quality Assurance (Phase I-IV) group within companies.
  • Experience in Auditing of NCE (New Chemical Entity) projects which included GLP /GCP/GMP compliance assurance.
  • Audited Pharmacovigilance and Clinical function globally - USA, Europe (UK, Ireland, Germany, Sweden, Romania, France, Italy, Austria), Africa, Asia, etc. since 2010 which included corporate PVG, regional offices, country offices, business partners/affiliates, service providers, etc., when she was working for Ranbaxy/
  • Has an experience IT systems used for Auditing, she has also a knowledge in Medical writing in pharmacovigilance e.g. Investigator Brochure, clinical trial protocols and Clinical Study Reports, Periodic safety update report (PSUR), Addendum to Clinical Overview (ADCO), CTD modules, safety narratives, etc. in accordance with the international guidelines.
  • Managed and facilitated due diligence visits / out-licensing of a NCEs and NCE co-development with Medicines of Malaria Venture, Switzerland and GSK.
  • Led the quality assurance programme for the IND directed studies and clinical development of Synriam, an antimalarial in Asia and Africa – India’s first new drug.
  • Working knowledge of performing Audit of GxP IT systems (including the Qualification documents) with respect to CFR Part 11/ Annex 11 requirements of Enterprise level Computer Systems.
  • Knowledge in Medical Writing/Pharmacovigilance writing e.g. Investigator Brochure, clinical trial protocols and Clinical Study Reports, Periodic safety update report (PSUR), Addendum to Clinical Overview (ADCO), CTD modules, safety narratives, etc in accordance with the international guidelines.
  • A Team leader & team player with demonstrated leadership skills having analytical bend of mind, good communication and interpersonal skills.
  • Received awards for demonstrating commitment and contribution in Quality assurance & Team Management.
Dr. Subodh Bhardwaj – Director Scientific & Medical Affaris – CRQA
An innovative Medical Doctor with Post Graduation in Pharmacology and more than 30+ years of experience in Clinical Medicine, Clinical Research, Pharmaco-vigilance and Regulatory affairs. Varied experience of 20 years in the Bio- Pharmaceutical Industry with reputed companies like Serum Institute Of India, Sanofi Pasteur, Aventis, Shanta Biotechnics, Serono, MBL, Crucell and interactions with WHO, Ministry of Health, DCGI, DBT, ICMR, IMA, IAP, OPPI, APACHE, APCRI.
Planned and completed over 100 clinical trials ranging from Pre-clinical, Phase1-4 and pharmaco-epidemiological studies. Possess exemplary skills in Regulatory affairs in India and fully updated on EU, US regulations. Have worked in Pharmaco-vigilance since 30 years with some interesting publications. Excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology. Over 60 publications in National & International Journals. Have actively published several product monographs, PILs and publications for public interest. Have been M.Pharm & Phd guide at University of Pune. Excellent Public speaking and Analytical skills. Widely travelled and have done clinical trials in 10 countries across the world. Proven track record in the health sciences field.
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
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