Objective :
Searching challenging opportunities in Project department or IVRS department of Clinical Research organizations to share the knowledge and apply skills, techniques to improve the performance level through continuous improvement.
Summary of Skills and Experience :
Skills : Able to work under minimal supervision.
Excellent organization, planning and problem solving abilities.
Excellent negotiation and analytical skills.
Established interpersonal and communication skills.
Fluent in English and other local languages both verbal and written.
Proficiency in computer.
Able to work effectively and efficiently in a demanding environment.
Knowledge Base :
** Sound knowledge of Global Clinical Trial Supplies & Clinical Trials.
** ICH, GCP guidelines
** Interactive Voice Response System and Interactive Web Response System
Currently working in Bilcare Research, Global Clinical Supplies department since Aug 2005
1) As Associate Manager-IVRS services since 2008
Project Management for IVRS/IWRS services :
** This includes, but not limited to : attending kick-off meetings, writing User Requirement Specifications, act as a liaison for developers and validators as necessary, conducting User Acceptance Testing, meeting deliverables and preparing materials for investigator meetings.
** Be able to enter data correction edits into the IVRS system and manage the change control process. Maintain/file documentation for study files.
** Answer IVRS Help Desk calls on an on-call basis, 24/7/365.
** Business development. Business development includes, but is not limited to : completing purchase ordering process, processing invoices, writing quotes for prospective clients, supporting the Bilcare sales team when meeting with clients.
** Documentation and SOP writing
** Complete project management for IVRS/IWRS projects
Project Management for general projects :
** To interact with clients and coordinate project related activities based on the timelines.
** To communicate the client requirements to the team members and to interact within the organization to coordinate project related activities and requirements.
** To interact with the vendors to procure the specific project related equipments, components etc.
** To interpret the protocol to understand clinical supply management requirements.
** To prepare the quotation for the packaging services to be provided to the client. To provide initial as well as final versions of the quotation.
** To prepare the project plan with the timelines for the client.
** To execute the project and ensure the completion of the project based on the timelines.
** To ensure that the primary packaging, secondary packaging, distribution, returns & destruction are executed as per client requirements.
** To do the inventory management of the drug product at the sites based on randomization or using IVRS.
** To prepare batch packaging records and seeking client approvals.
As Production officer from 2005-2008
GMP activities :
** Very well versed with the implementation of procedures for receipt, storage, packaging and distribution pharmaceutical products.
** Equipment Qualification and Facility Validation includes Preparation and Execution Equipment / Facility IQ/OQ and PQ Protocols, HVAC validation and Temperature mapping studies.
** Knowledge of Validation Master Plan and Site Master File as per International guidelines.
** Employee Training Management includes preparation of Training Calendar and Training Module.
** Preparation of Employee Training Matrix, Conducting Training Programs.
** Handling Regulatory and Customer Audits and its Compliance.
** Member of cross functional self inspection auditing team.
** Handling TOC (Total Organic Carbon Analyzer) and interpretation of test results.
** Basic knowledge of ERP system (SAP) and computer validation.
** Experience of MHRA audit
** Preparation of Site Master File, Validation Master Plan, SOPs, Batch packaging Records and Provides QA MP support by providing review for batch records.
** IPQC for operations of Primary (Blistering, Bottling) and Secondary packaging operations
** Knowledge of Clean rooms for pharmaceuticals.
Professional Qualification :
** B.PHARM : University of Pune Jun 2001 -Jun 2005 69%
** HSC : Maharashtra Board Jun1997-Jun1999 77.00%
** SSC : Maharashtra Board Jun1995-Jun1996 86.85%
** GATE : March 2005 92.83 percentile Qualified
Computer proficiency :
Power Point Presentation, MS office, MS word, Internet Surfing, MS Excel
Training :
1.
Attended 5 days training program on Clinical Supply Management given by Mr. Steve Jacob (Managing Director-Bilcare Clinical Services Center, USA).
2. Attended one day training workshop on `Cold Chain Management' by World courier.
3. Attended one day training seminar on `Cold Chain Management' by DHL Express Courier Ltd.
4. Attended IVRS/IWRS training by Bilcare USA IVRS specialist.
Profile Highlights :
1. Effective communication skills.
2. Excellent capability to understand working diverse culture and adapt to changes.
3. Good fluency in English, Hindi and Marathi.
Co-Curricular Activities :
1. Actively participated in 54th Indian pharmaceutical congress 2002 Pune as a volunteer.
2. Actively participated in NATIONAL PHARMACY WEEK 2003 as volunteer
Hobbies :
Internet Surfing, Learning and understanding new things, Listening soft Music and Dancing
Declaration : -
I hereby declare that the information furnished above is true completed to the best of my knowledge & belief.