| Urgent requirement Audit and Compliance Manager : Omaha, Nebraska (Onsite) at Omaha, Nebraska, USA |
| Email: [email protected] |
| From: Nitish Kumar, Quantum World Technologies Inc [email protected] Reply to: [email protected] Hello Hope you are doing well today!!! Position: Audit and Compliance Manager Location: Omaha, Nebraska (Onsite) Duration: Long time Contract Job Description: Role name: Audit and Compliance Manager Role Description: Dedicated 8 + yrs of Pharma /Life Science Regulatory experience for SOX, GXP Applications and Technical PlatformsGood Understanding of US FDA and other Pharma Regulations updates like 21 CFR Part 11, EU Annex, CSV, CSA methodology.Hands on exp of Leading assessment discussions with Corporate Auditors and External Audit TeamSupport data evidence phase for external governmental inspectionsGood experience in Design and drive closure of remediation activities coming out of AuditsBachelors degree in a relevant field such as Life Sciences, Engineering, Technical Communication, or a related discipline.Advanced degrees or certifications in technical writing or scientific communication.Minimum of 5 years of experience in Regulatory Technical Writing in a GxP or manufacturing environment.Strong understanding of bio-pharma processes, SDLC, and regulatory requirements.Experience with electronic document management systems (EDMS) / CARAProven experience in creating clear, concise, and accurate technical documentation.Proficiency in documentation tools and software (e.g., MS Office Suite, TEAMS, etc.).Excellent written and verbal communication skills.Ability to work independently and manage multiple projects with tight deadlines.Detail-oriented with strong organizational skills.ITIL Certification is a must; excellent knowledge of ITSM processesAbility to participate in steering committee meetings. Competencies: Digital : Risk Regulatory Compliance Analytics Experience (Years): 8-10 Essential Skills: Dedicated 8 + yrs of Pharma /Life Science Regulatory experience for SOX, GXP Applications and Technical PlatformsGood Understanding of US FDA and other Pharma Regulations updates like 21 CFR Part 11, EU Annex, CSV, CSA methodology.Hands on exp of Leading assessment discussions with Corporate Auditors and External Audit TeamSupport data evidence phase for external governmental inspectionsGood experience in Design and drive closure of remediation activities coming out of AuditsBachelors degree in a relevant field such as Life Sciences, Engineering, Technical Communication, or a related discipline.Advanced degrees or certifications in technical writing or scientific communication.Minimum of 5 years of experience in Regulatory Technical Writing in a GxP or manufacturing environment.Strong understanding of bio-pharma processes, SDLC, and regulatory requirements.Experience with electronic document management systems (EDMS) / CARAProven experience in creating clear, concise, and accurate technical documentation.Proficiency in documentation tools and software (e.g., MS Office Suite, TEAMS, etc.).Excellent written and verbal communication skills.Ability to work independently and manage multiple projects with tight deadlines.Detail-oriented with strong organizational skills.ITIL Certification is a must; excellent knowledge of ITSM processesAbility to participate in steering committee meetings. Desirable Skills: Dedicated 8 + yrs of Pharma /Life Science Regulatory experience for SOX, GXP Applications and Technical PlatformsGood Understanding of US FDA and other Pharma Regulations updates like 21 CFR Part 11, EU Annex, CSV, CSA methodology.Hands on exp of Leading assessment discussions with Corporate Auditors and External Audit TeamSupport data evidence phase for external governmental inspectionsGood experience in Design and drive closure of remediation activities coming out of AuditsBachelors degree in a relevant field such as Life Sciences, Engineering, Technical Communication, or a related discipline.Advanced degrees or certifications in technical writing or scientific communication.Minimum of 5 years of experience in Regulatory Technical Writing in a GxP or manufacturing environment.Strong understanding of bio-pharma processes, SDLC, and regulatory requirements.Experience with electronic document management systems (EDMS) / CARAProven experience in creating clear, concise, and accurate technical documentation.Proficiency in documentation tools and software (e.g., MS Office Suite, TEAMS, etc.).Excellent written and verbal communication skills.Ability to work independently and manage multiple projects with tight deadlines.Detail-oriented with strong organizational skills.ITIL Certification is a must; excellent knowledge of ITSM processesAbility to participate in steering committee meetings. Thanks & Regards, Nitish Kumar Sr. Technical Recruiter Quantum World Technologies Inc [email protected] Contact No: 8055742738 Keywords: microsoft Urgent requirement Audit and Compliance Manager : Omaha, Nebraska (Onsite) [email protected] |
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| Fri Aug 23 05:17:00 UTC 2024 |