| Audit and Compliance Manager - OMAHA at Omaha, Nebraska, USA |
| Email: [email protected] |
| From: Mahesh Kumar, KK Associates LLC [email protected] Reply to: [email protected] Hi, We have below job opportunity with one of our clients. If you have any matching profiles please get in touch with me 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. Country: United States Branch | City | Location: USA OMAHA QWEST COMMUNICATION Keywords: FDA, EMA, and ICH guidelines, 21 CFR Part 11, EU Annex, CSV, CSA Email is the best way to reach me if I missed your call Regards, Mahesh Kumar KK Associates LLC. 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite # 100, Dublin, OH 43017 Direct: 925-298-0978 Email: shetty.m @kksoftwareassociates.com Web: www.kksoftwareassociates.com Keywords: microsoft Ohio Texas Audit and Compliance Manager - OMAHA [email protected] |
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| Fri Aug 23 06:17:00 UTC 2024 |