*Dear Folks / Business Partners,* * *
*We are in desperate need for Pharmaceutical Quality and Compliance Specialists* *........Long term....Immediate Joining*** * * *Location – **NJ or PA,* * * *Duration – **Long Term*** * * *POSITION SUMMARY:* Pharmaceutical Quality and Compliance Specialists for computer systems validation *DUTIES & RESPONSIBILITIES:* * * Ø *Mandatory Core Competencies * Ø Analytical and problem solving skills Ø Complex problem solving abilities across operational, organizational and strategic matters Ø Experienced in Pharmaceutical Quality assurance function, Faced FDA / MHRA audits including Computer system validations Ø Good understanding of Software Development Life Cycle, S/W Engineering Concepts Ø Proficiency in Microsoft Office products, such as Excel, Word, PowerPoint etc Ø Preference for exposure to Specific systems knowledge and experience (e.g. SAP, Oracle, CAPA--Track wise, LIMS, Documentum, Livelink, etc.) *Life Science Industry Core Competencies (Desirable)* * * Ø Industry sub-segment experience (e.g. Pharmaceutical, Medical Device, Biotechnology) Ø Regulatory knowledge (e.g. EMEA, FDA, GxP, HC, ICH, ISO, MHLW, MHRA, PDMA, 21 CFR Part 210, 211, 11, PIC/S, etc.) Ø Operational area (e.g. R&D/Clinical, Operations/Manufacturing, Quality Assurance/Control, Supply Chain) Ø Process knowledge and experience (e.g. Research and Development, Manufacturing –Production, Quality control, Quality assurance, Regulatory affairs etc.) Ø Exposure to Preferred Systems as Functional Users and Validation Experts (e.g. AERS, CAPA, EDMS, EQMS, ERP, LIMS, MES, PLM, etc.) *POSITION & QUALIFICATION REQUIREMENTS:* * * Ø Educational Qualifications: BSc/MSc/B.E/B.Tech/M.E/M.Tech/M Pharm/PhD Ø Work Experience: 7 to 15 years Ø Strong communication skills, interpersonal skills, team work. A demonstrated commitment to company values. *If interested please send me your resume, and also answer to the questions below* * * Ø Candidate Contact Number Ø Candidate Visa Status Ø Candidate Convenient time to take up the telephonic discussion Ø Candidate convenient time to take up the face to face discussion Ø Candidate Employer details if in case of H1B Ø Candidate Current billing rate Ø Candidate Expected billing rate Ø References of direct supervisor * * Thanks & Regards, Kumar Javaji System Solutions Inc., 703 880 4142 703 880 7232 (Fax) [email protected] Google IM: kumar4mjss www.javaji.com *Javaji systems is a global provider of IT recruitment, software development and IT services. We deliver a measurable delta in productivity, profitability, and shareholder value to the world’s leading companies. Our Methodology enables clients to lower the total cost of ownership and meet their business objectives.*** -- You received this message because you are subscribed to the Google Groups "Ajax-DOT-NET-FAQ" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/ajax-dot-net-faq?hl=en.
