Tuesday, June 28, 2011

{Ajax-DOT-NET-FAQ} Urgent opening for Pharmaceutical Quality and Compliance Specialists at NJ & PA........Long term....Immediate Joining(Must)

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)

kumar@javaji.com

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.

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