Your Trusted Partners for Quality Assurance and Regulatory Services…
GxP Auditor
QA Director
  • She comes with an extensive experience in Quality assurance with her core competence in planning and delegating audits.
  • She has handled inspections and conducted more than 20 site audits and 8 vendor audits
  • She has conducted audit for a global Phase III program for gastroenterology tertiary care super specialty hospital in Delhi.
  • She has as a part of Sponsor QA program of large phase III Oncology Study on DLBCL has performed Site Audits at 6 high recruiting sites, suggested CAPA, supported team in implementing CA and ensured escalation of critical compliance issues.
  • Our Auditor also has an experience in facing FDA Inspection at a Site in Delhi for a global Phase III study.
  • She performed Mock Inspection programme for private multispecialty hospitals as part of their FDA Inspection preparation programme.
  • As part of training and development our Auditor has also conducted Corporate GCP training programmes for investigators, Ethics committees and site teams.
  • Trained and prepared several Institutional Ethics Committees for regulatory inspections.
  • She was also GCP consultant for a Dedicated Dermatology CRO
  • She has experience in monitoring Phase I study of Colon and Colorectal Cancer in Stage III b patients which involved overseeing of housing, dosing, and blood sampling of patients in the hospital set up.
  • Her experience in clinical research also includes Project Management of a global, therapeutic equivalence study on anti-acne product running in 10 sites in India and evaluation of 3 BA/BE CROs with Client for phase I trials in Diabetes and Acne Studies.
  • She was also a corporate trainer and imparted training in Clinical Operations, Monitoring (Basic and Advanced Level) Quality Assurance and Quality Control in clinical trials, SOPs, Audits, Inspections, Clinical trial management to CRAs, Senior CRAs, Project Managers, HODs etc.
GxP Auditor
  • Our Auditor comes with comprehensive experience of 20 years specializing in Clinical trials (Phase-I to IV), Bioavailability & Bioequivalence Studies, Documentation Procedures and Quality Systems.
  • Has audited all the major CROs in India for their systems and processes for efficiency and compliance.
  • Has provided Regulatory Support through alliance partners for getting BE-NOC, T-License etc. from the State Regulatory bodies.
  • Has hosted inspections of various regulatory agencies (US-FDA, affsaps, ANVISA, AGES-Austria) of the facility and the scientific data leading to no major observations or findings.
  • Has implemented quality systems as per USFDA cGLP, cGMP guidelines and have conducted quality system audits for a multinational clinical research giant
  • Formerly Head for clinical research operations and has led and mentored a team of over 60 individuals across diverse verticals- Bioanalytical, PK & Statistical, Clinical Operations, Medical Writing, and Regulatory affairs.
  • Was also the Head of Bioanalytical and Pharmacokinetic Operations where in which his key responsibilities included as that of a Study Director for all the assigned clinical trials done In-house, giving PK inputs for all the study protocols, and reviewing PK and statistical analysis for its authenticity and accuracy.
  • Prior to his work as the Head of operations she was appointed as Senior Research Scientist for Clinical Pharmacology and Pharmacokinetics where in which she conducted around 100 pilot and pivotal bio-availability and bio-equivalence studies for various immediate release, delayed release and extended release formulations as per approved protocols to assess their pharmacokinetic behaviour.
  • Has authored many international publications on drug development.
Pharmacovigilance Auditor
He is an MD in Internal Medicine and has over 18 years of experience in the field of Medicine, Pharmacovigilance and Clinical Research. In his last assignment, he was the Vice President of Safety and Medical Affairs at APCER. Just before joining APCER, Sanjeev was the Vice President for Pharmacovigilance and Medical Writing at Accenture. Before joining Accenture, he was the COO Officer and Scientific Director of CIDP Biotech. Prior to CIDP, Sanjeev was the Director of Medical Affairs at CliniRx. Before CliniRx, He has worked with Ranbaxy as a Senior Manager in the department of Medical affairs and Pharmacovigilance. He has also worked as a Senior Resident in Cardiology and Medicine Department in some of the prestigious hospitals of New Delhi. He is a life time member of API and a fellow of Indian Association of Clinical medicine. He has numerous publications in medical journals and books to his credit.
Pharmacovigilance Auditor
Auditor has over 14 years of experience including Pharmacovigilance and clinical research. She was Associate Vice President for US PV and clinical safety at APCER in her last role and was overseeing the delivery and operations from India which included but not limited to case processing aggregate reporting, literature monitoring and signal detection. Before joining APCER, she was with Ranbaxy as a Manager in the department of Medical affairs and Pharmacovigilance. She comes with an extensive experience in various safety databases like Argus Safety and ARISg for case processing, reporting, and product/license management and has also met the challenges of business continuity planning and data restoration.
Senior Pharmacovigilance Auditor
Pharmacovigilance Quality Management System, PVQMS
  • Oversee and ensure improvement of the Pharmacovigilance Quality Management System, PVQMS, (procedures and working practices) to meet global Pharmacovigilance requirements.
  • Ensure the PVQMS is aligned and integrated with the Global Quality Management System
  • Organise and prepare documentation for Compliance Management Review of the PVQMS.
AUDIT – External
  • Develop and maintain a risk based audit procedure for Pharmacovigilance activities carried out for vendors, CROs on behalf of sponsor. Carry out audits as per the requirement of Good Pharmacovigilance Practice Guidelines, ICH guidelines, EU Directives, Eudravigilance, WHO Guidelines, Medical Device Legislations, Cosmetovigilance & Supplement Vigilance.
  • Ensure audit plan is delivered, associated CAPAs are managed and records are maintained. Monthly summaries are published to interested parties.
  • CAPA Management System ownership for PVQMS activities.
AUDIT – Internal
  • In conjunction with the QA senior management publish an annual internal audit plan designed to audit all key PV systems on a 2 year cycle.
  • Approved audit plan to be published to all interested parties (eg Chief Medical Officer, Global Head of PV, EEA QPPV, National PV Contact Persons, Medical Compliance Officer) and in the PSMF.
  • Ensure audit plan is delivered, associated CAPAs are managed and records maintained. Monthly summaries are published to interested parties.
  • Develop and deliver training on PVQMS to key personnel to ensure PVQMS requirements are understood at the appropriate levels for all staff in all countries.
  • Deliver training to 3rd party service providers as agreed to support from QA team training plan. Plan to be reviewed annually at a minimum with Global QA Group and Global Head of PV.
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
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.
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.
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to
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