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
Kumar
Javaji System Solutions Inc.,
703 880 4142
703 880 7232 (Fax)
Google IM: kumar4mjss
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.
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