Sameer Mundke

About Sameer Mundke

As a Quality Senior Specialist in Teva Pharmaceuticals, I have extensive experience in auditing BA/BE studies, both pre and post-study, in accordance with the relevant GCP/GLP guidelines, protocols, and SOPs implemented within the department(s) of WPPL BEC site. I plan and execute the necessary inspections and audits to support the study, ensuring compliance with all applicable regulatory requirements. Additionally, I conduct internal study audits, system audits, general audits, and external contractual audits to ensure compliance with GCP/GLP, Protocols, SOPs, and applicable regulatory requirements. Prior to my current role, I worked as an Officer - Quality Assurance in Raptim Research Pvt Ltd, where I reviewed the generated raw data of bioanalytical studies and validations thoroughly for correctness. I also conducted internal study audits and general audits to ensure compliance with GCP/GLP, Protocols, SOPs, and applicable regulatory requirements. Additionally, I maintained the accountability of forms, records of inward and outward documents to the bioanalytical section from the QA section, and ensured compliance with relevant checklists. My experience in the field of quality assurance also extends to my previous role as a Chemist - R&D at Nutrizo Wellness Pvt Ltd. Here, I conducted research work related to sugar-free products and conducted various trials of R&D batches. I also communicated with vendors for respective ingredients and supervised the production team for the manufacturing of final products. Throughout my professional career, I have ensured periodic reviews of all quality functions and procedures for appropriateness and validity. I have also reviewed generated raw data and respective validation reports, addendums, bioanalytical reports, and ensured implementation of corrective action and closed audits. Additionally, I have prepared audit reports in adherence with guidelines, written procedures, and regulatory inspections, and prepared compliance reports on behalf of the unit. With my experience and expertise in quality assurance and auditing, I am confident in my ability to contribute positively to any organization. I am a dedicated and detail-oriented professional with a passion for ensuring compliance with regulatory requirements and quality standards.

Experience

1. Senior Quality Assurance Specialist

   Teva Pharmaceuticals

   Apr 2020 — Present · Navi Mumbai, IN

   Audit BA/BE studies (both pre and post study) in conformance with the relevant and current GCP / GLP guidelines, protocols and SOPs implemented within the department(s) of WPPL BEC site- Plan and execute the inspection and audit, necessary to support the study- Conduct internal study audit, system audits, general audit and external contractual audits for compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements- Review of generated raw data and respective validation report, addendum, Bioanalytical report generated from method validation, partial method validation, and subject sample analysis- Ensure periodic review of all quality functions and procedures for appropriateness and validity- Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections- Prepare a compliance report on behalf of the unit, ensure implementation of corrective action and close the audit

Education

• Oriental college of pharmacy

  M pharmacy

  2015 — 2017

• Mumbai University

  B-pharmacy

  2010 — 2013