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WASEEM MOHAMMEDHyderabad | 00918885400912 | [email protected]
PERSONNEL PROFILE
Confident, result driven, personal want to be a CRA/Clinical SAS programmer with distinguished experience in Pharma sector with 2+ years of experience in quality management, FMCG. As a proactive team builder and tactical planner have ability to secure key elements of business and build long lasting relationship.
CORE COMPETENCIES
Knowledge and understand on the concepts of Drug development, Clinical trial phases (I-IV), ICH-GCP,US FDA,MHRA Guidelines, Schedule Y, roles and responsibilities of clinical trial team, Inform consent process , site initiation study, SOPs, IB, IP, Protocol Design and format, 21CRF PART 11, Clinical data management, CRF designing, Data validation, Query management, Safety data management, CDISC- STDM. Good knowledge of GMP/GLP/GCP guidelines.
Knowledge and understanding of area such as immunology, Hematologic, and inflammation studies. Able to search and understand various patents databases like EU, US, IP and others.
Knowledge and Handling of various instruments like IR, UV, HPLC, NMR, GC, and Karl-Fisher. Good experience of purification of rich synthesized compounds by crystallization, various chromatography
techniques like GC, Preparative TLC.
PROFESSIONAL EXPERIENCES & PROJECTS
Nov 2013 – Feb 2015 Quality Assurance Coordinator NSF Pharma PVT LTD India
Activities: Effective communication for required documents, Quality assurance audit, Document preparation and submission.
Responsibilities:
Plan, conduct, report and follow-up of QA audits under the supervision of the line manager. To ensure compliance to applicable regulations, guidelines, SOPs and appropriate, processes requirements. Build, develop and maintain good working relationships with all internal customer groups. Liaising with the
divisions of Logistics Services, Procurement and Quality Management Responsible for all QA Documents including all Master Documents, Master Formulas, BMR’s, Site Master File,
SOP’s, Validation Protocols, Audit Surveillance Report etc. To perform approval activities of line clearance process and ensure the process is followed as per standards, to
ensure online documentation during production and packing activities. Pre Dispatch Quality Audit of Finished Goods, dispatch of Finished Product and review of COA prior to release.
Preparation, Issuance, retrieval of BMR’s & BPR’s and their Archival. Review of Analytical/Inspection records of Bulk and Finished product, Raw and Packing material. Giving
feedback to Quality Manager. Product and taken the CAPA (Corrective and Preventive Action). Execution of Process Validation Activities. Preparation of Annual Product Review.
Regulatory Affairs New Market Penetration Quality Management Market Research & Analysis Document evaluation and submission Team Building & Leadership Business Development
Sales Marketing and Project Execution Client/Vendor Management Key Accounts Management
Jan 2012 – Nov 2013 Customer Service Management Sainsbury Plc. – U.K
Activities: New Business Implementation & Customer Relation Management
Responsibilities: Food quality Management Worked as responsible associate to implement new concept of business in designated department. Responsible to work as a team and help to increase Sales figure by 15% from last year. Worked as liaison between Implementation and Business Development team in New Product Development. Played crucial role in Business Analysis, Product Testing and Technical Implementation. As a team member, responsible for management and delivering excellent customer services. Responsible to identify product and service relationships in a popular combination which help to cross-sell and up-sell. Take initiative to maintain good relationship between Business and Customer by various customer satisfaction and
retention tactics.
EDUCATION
Advance Post Graduate Diploma Clinical Trials, Pharmacovigilance, CDM (6 months Internship) Medwin Hospital Clinical Research Organization India Feb2013
Diploma in Medical Assistant Feb2010 – Oct2010NPA UK
Bachelors of Pharmacy Nov 2005 - May 2009 Osmania University Hyderabad India
Personal Information
Skype ID: wasimfa Notice Period: Immediately Passport: F8887841 Nationality: Indian DOB: 11 Jan 1985
Current CTC: 1.8 Lakh P/A Expected Salary: as per company standard Certification
Certified SAS Base 9 credential London 2012
References
Shaik Jani (HOD Quality and Production) NSF Pharma PVT LTD [email protected]
Anthony (Store Manager) [email protected]
G.V.L.P Subba Rao (CEO) Medwin Hospital [email protected]
