Compliance Manager -pharma and Life Sciences

Sampoorna Computer People
  • Mumbai
  • 10-15 lakh
  • 9-14 years
  • 02 Apr 2015

  • IT/ Information Technology

  • IT/ Technology - Software/ Services
Job Description

Skills :
-Strong knowledge on Global regulations for the Pharma, Life sciences and Medical devices Industry.
-Strong understanding of Software development life cycle with strong IT skills for the Pharma and Life sciences products. IT Infrastructure qualification Knowledge for Life sciences domain. Good Communication Skills
-Relevant work experience in working to support Quality and Compliance Organizations
-Excellent understanding of Computer System Validation / Part 11 requirements for Lab, Clinical, Manufacturing systems. Good understanding of applicable GxP / Regulations applicable to pharma/medical device value chain.
-Capabilities to prepare and execute validation deliverables. Relevant/significant experience in Computer Systems Expertise in GAMP (1-5) Validation. Expertise in ERP validations.
-Strong written and oral communication skills to the executive level.
-Sales and Business Development Skills in Pharma and life sciences Industry.
-Familiarity with IT security requirements
-Familiarity with Internal Quality/Compliance Audit and IT Supplier Quality Audit programs
-Experience within IT Service Management framework

Competencies/Skill sets for this job

Life Sciences Gxp Quality Pharma Regulations

Job Posted By

About Organisation

Sampoorna Computer People