Surabhi Buaria

Freelancing consultant - helping pharmaceutical companies in the areas like: Regulatory affairs documentation, Audit manufacturing facilities of vendors, cGMP trainer - Imparted training to organizations based on cGMP requirements as per 21CFR part 210 and 211, Q7A, ICH, etc. ISO Technical Expert - Conducting ISO 9001 Audits along with Lead Auditors

 Overall responsibility of handling QMS and Regulatory affairs.  Review and documentation of QA / QC and RA departments.  Compliances and audits.  Dossier review and submissions.  Imparting Trainings.  Managed a team of 7 FTEs.

Filing of COS in EDQM and handling regulatory queries, USP verification program for dietary supplements, Managed ANDA filings, Technical Support to International Marketing Team, Responsible for setting up cGMP quality systems for a green field project. Regulatory fillings in regulated and semi- regulated markets. Managed a team of 10 FTEs.

Managed staff of 10 QC chemists. Regulatory Affairs: Submission of Technical Dossier to various Asian countries, Brazil, Mexico, Peru, Jamaica, etc. for Cephalosporin powder for injections. Regulatory documentation. Quality control: from sample receipt to final release. In-process quality control activities, co-ordination with QA and production.

QUality management and documentation.

Taught subjects Pharmaceutical Chemistry, Pharamceutics and practicals related to relevant subjects.

Worked in Quality Assurance and Quality control Department at US FDA approved site.