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CV_Clin_Reshma 24 Jan 17

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CV_Clin_Reshma 24 Jan 17

  1. 1. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 1 of 6 Currently working at: Dr. Reddy’s Laboratories Ltd, Hyderabad, India Designation: Manager, Clinical Quality Assurance SUMMARY Worked as a Clinical QA auditor in Clinical development function and Quality Reviewer for clinical trial documents for phase I to Phase IV domestic and international clinical trials with a variety of therapeutic areas under the new drug development including biosimilars. Performed and coordinated all the audit related activities starting from preparation of audit plan, audit intimation letter to conduct of onsite and remote audit, audit report preparation and review of CAPA response. Performed quality review of the clinical trial documents as per Protocol, SOPs, ICH GCP guidelines and local regulatory requirements. The eye for detail during the quality review of the documents was much appreciated within the functional department. CURRENT POSITION Manager, Clinical Quality Assurance at Biologics, Dr. Reddy’s Laboratories Ltd, Hyderabad, India (January 2008 – till date) CURRENT JOB PROFILE ● Conduct of quality reviews of protocol and amendments, ICFs, IB, clinical study reports, Addendum to CSR, Annotated CRF, SmPC, CTD modules in addition to review of tables, figures and listings and other supplementary clinical trial documentation. ● Perform GAP analysis of Clinical trial projects by review of project specific documents, Protocol, sponsor oversight plan, ICF, MV reports, safety letters and contracts. ● Check documents generated for discrepancy between source data and document, discrepancy within text and discrepancy between figures, tables and text and review the content of the documents from scientific and regulatory perspective.
  2. 2. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 2 of 6 ● Effectively perform review of documents to ensure they are of highest standards of quality. ● Provide support to cross functions in developing SOPs. ● Participate in risk based on investigator site audits as a co-auditor and as sponsor representative and prepare audit plan, audit intimation letter, conduct of audit and review and finalisation of audit reports. ● Conduct vendor audits both onsite and remote by preparation of audit plan, audit intimation letter, conduct of audit and review and finalization of audit reports. ● Plan and perform remote audits of the eCRF for clinical studies. ● Track and escalate quality issues in clinical department. ● Maintain clinical QA systems with written standard operating procedure (SOPs), Work instructions, Policies and manuals. ● Support local and global health authority (HA) inspections and third party audits. ● Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit. ● Perform timely management of audit metrics and root cause analysis of non- compliances. ● Train team on Clinical Quality Assurance SOPs. ● Identify emerging trends/regulations/policies in clinical research of biosimilars development while proactively integrating these elements into internal and external procedures. ● Coordinate training management and archive management. ● Support in management of document control. ● Review CIOMS during reporting of SAEs to the local regulatory. ● Support PV QMS set up by preparation of SOPs. ● Participate in clinical operation team meeting to escalate quality issues in the investigator site.
  3. 3. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 3 of 6 PREVIOUS POSITIONS Assistant Manager, Quality Assurance department at Biologics, Dr. Reddy’s Laboratories Ltd, Hyderabad, India (July 2010-July 2014) ● Perform Investigator site audit and coordinate all the audit related activities starting from preparation of audit plan, audit intimation letter to conduct of onsite audit, audit report preparation and review of CAPA response. ● Perform QC of the monitoring reports and provide inputs to Operational team. ● Conduct Vendor audits for Phase III clinical trials and coordinate all the audit related activities starting from preparation of audit plan, audit intimation letter to conduct of onsite audit, audit report preparation and review of CAPA response. ● Maintain clinical QA systems with written standard operating procedure (SOPs). ● Perform quality reviews of Protocol, ICF and CSR and other clinical trial documents. ● Review of PSURs to the Indian regulatory authority (DCGI) as per existing drug regulations. Junior Manager, Quality Assurance department at Biologics, Dr. Reddy’s Laboratories Ltd, Hyderabad, India (Jan 2008-July 2010) ● Maintain clinical QA systems with written standard operating procedure (SOPs). ● Participate in clinical systems meeting and prepare MOMs and circulate to attendees. ● Perform the review/ audit of Bioanalytics-Method development reports, method validation protocol, method validation reports, immunogenicity reports and PK reports ● Support development of GMP QMS SOPs such as Training management, change management and discrepancy management. ● Support in the closure of change controls. ● Performed quality reviews of Clinical trial Protocol and PSURs. ● Perform internal system audits for Pre-Clinical and Clinical functions ● Provide support in setting up systems in preclinical toxicology function
  4. 4. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 4 of 6 PREVIOUS WORK EXPERIENCE ➢ Scientist II – Torrent Research Centre, Ahmedabad, India (Jul 2004 –Oct 2007) Past Clinical Trial profile ● Involved in trial related activities like o Protocol and Informed Consent Form generation and Report generation (pooled and centre wise) o Ensure compliance with ICH-GCP, ICMR or other regulations and guidelines as well as relevant company SOP’s and protocols. o Accompanied the monitor during the site initiation and site monitoring of the local sites. o Conduct monitoring of the CROs and preparing the monitoring reports. o Coordinate with the CROs. o Coordinate and distribute clinical study materials to clinical sites. o Preparing for Ethics Committee submission. o Organize and present the protocols in the ethics committee meetings. o Provide assistance with preparation and submission of CT/BE Applications. o Conduct of Bioavailability/Bioequivalence Studies. o Test-license (Formulation/Bulk drug) and Narcotic licence application. o Involved in preparing application for phase I trial. o To prepare and submit Manufacturing and Marketing application for submission to DCG (I) as per Schedule Y requirements. International Operation Division (IOD): ● Faced ANVISA (Brazil) inspection at Pharmacokinetic Unit of Torrent Research Centre during 2004, 2005, 2006 and 2007. ● Faced UAE audit at pharmacokinetic unit in 2007
  5. 5. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 5 of 6 EDUCATIONAL QUALIFICATIONS: Master in Pharmacy from Manipal College of Pharmaceutical Sciences, Manipal, affiliated to Manipal Academy of Higher Education, Manipal Specialization: Pharmacy Practice GCP RELATED TRAININGS ATTENDED: ● Participated in the annual GCP training on 11 Mar 2016 by Arkus Clinical Trial Support Solutions at Dr. Reddy’s Laboratories Ltd, Hyderabad, India. ● Participated in “Advanced GCP workshop” conducted on 22 Jan 2015 by QMatra services at Dr. Reddy’s laboratories Ltd, Hyderabad, India ● Participated in Annual GCP training organised by Dr. Reddy’s Laboratories Ltd on 29 November 2011 at Dr. Reddy’s Laboratories Ltd, Hyderabad, India. ● Participated in workshop on ICH-GCP conducted by Arkus Clinical Trial Support Solutions and Organized by Dr. Reddy's Laboratories on 16th and 17th July 2010 at ICRISAT, Hyderabad, India. ● Participated in Medical writing workshop conducted by Dr. Barry Drees and organized by Dr Reddy’s Laboratories on 27 and 28 June 2008 at Dr Reddy’s Laboratories, Hyderabad. ● Participated in workshop on quality systems in clinical research conducted by Arkus Clinical Trial Support Solutions on 9 and 10 May 2008 at Mumbai. ● Participated in the workshop on “Development of SOPs, Guidelines, and Training modules for Good Clinical Practice (GCP) Programme for New Drug Clinical Trials” in the Country organized by GOI/WHO collaborative project held at B. L. Nair Medical College Hospital, Mumbai. ● Participated in the workshop on “ICH -GCP guidelines to conduct clinical trials” at KMC Hospital, Manipal, held on 21st and 22nd October 2005. ● Attended the 'International Seminar on Pharmacovigilance and Medicine Safety' held at JSS College of Pharmacy, Mysore ● Attended the 'National Seminar on Clinical Pharmacy Update’ held at College of Pharmaceutical Sciences, Manipal, Karnataka
  6. 6. RESHMA RUDOLPH D’ ALMEIDA E-mail: reshmayb@rediffmail.com Mobile: +91-9000660461 Page 6 of 6 PERSONAL DETAILS Sex: Female Nationality: Indian Marital status: Married Languages known: English, Hindi, Kannada, Konkani, Tulu PERMANENT ADDRESS 405, Block 11 Divya Sree Shakti Apartments Mayuri Nagar Miyapur, Hyderabad References: On request

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