CSV Specialist
Role:
CSV SpecialistLocation:
Raritan, NJ (Onsite from Day-1Job Type:
Contract Duration:
18
Months
Job Description:
Mandatory Skills:
CSV, 21 CFR part 11, Data integrity, Archiving
Responsibilities:
Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation Responsible for the quality oversight of GxP regulated computerized systems (e.
g.
manufacturing plant systems, laboratory systems and enterprise applications).
Manage the release of regulated systems for GxP production use Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU) In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits Minimum
Qualifications:
Bachelor's or Masters degree in science, computer science, or relevant area English, fluently spoken and written Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV In-depth knowledge of computerized quality systems Experience with GMP inspections Competences:
Communicative skills Negotiation skills Convincing Team player Accuracy Problem solver Thanks and Regards, Ravinder Molugu Senior US IT RecruiterPhone:
x Extn:
9055Direct:
+1 Email:
Recommended Skills Auditing Biotechnology Certified Global Meeting Planner Communication Corrective And Preventive Action (Capa) Information Technology Estimated Salary: $20 to $28 per hour based on qualifications.
CSV SpecialistLocation:
Raritan, NJ (Onsite from Day-1Job Type:
Contract Duration:
18
Months
Job Description:
Mandatory Skills:
CSV, 21 CFR part 11, Data integrity, Archiving
Responsibilities:
Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation Responsible for the quality oversight of GxP regulated computerized systems (e.
g.
manufacturing plant systems, laboratory systems and enterprise applications).
Manage the release of regulated systems for GxP production use Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU) In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits Minimum
Qualifications:
Bachelor's or Masters degree in science, computer science, or relevant area English, fluently spoken and written Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV In-depth knowledge of computerized quality systems Experience with GMP inspections Competences:
Communicative skills Negotiation skills Convincing Team player Accuracy Problem solver Thanks and Regards, Ravinder Molugu Senior US IT RecruiterPhone:
x Extn:
9055Direct:
+1 Email:
Recommended Skills Auditing Biotechnology Certified Global Meeting Planner Communication Corrective And Preventive Action (Capa) Information Technology Estimated Salary: $20 to $28 per hour based on qualifications.
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