PuroClean Certified Restoration Specialist of Auburn
CSV Specialist
PuroClean Certified Restoration Specialist of Auburn, Raritan, New Jersey, us, 08869
Job Type:
Full Time
Education:
B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD CodingJob DescriptionResponsibilities:Provide compliance leadership, direction and oversight to project teams in the area of Computer System ValidationResponsible 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 useParticipate 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.Requirements:Bachelor's or master's degree in science, computer science, or relevant areaEnglish, 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/CSVIn-depth knowledge of computerized quality systemsPharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand#J-18808-Ljbffr
Full Time
Education:
B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD CodingJob DescriptionResponsibilities:Provide compliance leadership, direction and oversight to project teams in the area of Computer System ValidationResponsible 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 useParticipate 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.Requirements:Bachelor's or master's degree in science, computer science, or relevant areaEnglish, 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/CSVIn-depth knowledge of computerized quality systemsPharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand#J-18808-Ljbffr