| Resume alert | Resumes 1 - 10 of 74 |
Quality Control Assurance
Hyderabad, Telangana, India
... • Currently working with Graviti Pharmaceuticals Pvt Limited – An US-FDA approved Formulations Company in Hyderabad as AGM – Quality since Jun-2017. • Worked with Novast Laboratories Limited – An US-FDA approved Formulations Company in Nantong, ... - 2023 Sep 17
... • Currently working with Graviti Pharmaceuticals Pvt Limited – An US-FDA approved Formulations Company in Hyderabad as AGM – Quality since Jun-2017. • Worked with Novast Laboratories Limited – An US-FDA approved Formulations Company in Nantong, ... - 2023 Sep 17
Regulatory Affairs Business Development
Hyderabad, Telangana, India
... Outstanding analytical abilities, problem-solving, decision-making, and interpersonal skills CORE COMPETENCIES Regulatory Affairs, Life Cycle Management Understanding of ICH, FDA, and other regulatory requirements Microsoft Office - Word, Excel, ... - 2023 Jan 03
... Outstanding analytical abilities, problem-solving, decision-making, and interpersonal skills CORE COMPETENCIES Regulatory Affairs, Life Cycle Management Understanding of ICH, FDA, and other regulatory requirements Microsoft Office - Word, Excel, ... - 2023 Jan 03
Communication, Organization, Project Management, Team work
Hyderabad, Telangana, India
... to add value to the operations execute TOOLS EXPERIENCE: •ISI Publisher & eCTD Express •Extedo eCTD Manager •View Point & Quantum •Common European Submission platform (CESP) •Veeva Vault •FDA ESG Gateway •EMA Gateway •Liquent Insight manager (RIMS). ... - 2022 Aug 29
... to add value to the operations execute TOOLS EXPERIENCE: •ISI Publisher & eCTD Express •Extedo eCTD Manager •View Point & Quantum •Common European Submission platform (CESP) •Veeva Vault •FDA ESG Gateway •EMA Gateway •Liquent Insight manager (RIMS). ... - 2022 Aug 29
A Senior Quality Professional with Hands-on experience
Hyderabad, Telangana, India
... Excellent leadership during remediation activities and lead most recent US FDA and MHRA successful inspections for Injectable, OSD and API Plants (2019, 2018, 2017, 2016, 2015). Never received warning letters. Certified Quality Auditor from American ... - 2022 Apr 30
... Excellent leadership during remediation activities and lead most recent US FDA and MHRA successful inspections for Injectable, OSD and API Plants (2019, 2018, 2017, 2016, 2015). Never received warning letters. Certified Quality Auditor from American ... - 2022 Apr 30
Power Project Pp
Hyderabad, Telangana, India
... Food and Drug Administration (FDA). Roles and Responsibilities: Created inspection lots, results recording, usage diction, stock posing. Created MIC like qualitative and quantitative using QS21 Created sampling Procedure by using QDV1 and Inspection ... - 2022 Jan 23
... Food and Drug Administration (FDA). Roles and Responsibilities: Created inspection lots, results recording, usage diction, stock posing. Created MIC like qualitative and quantitative using QS21 Created sampling Procedure by using QDV1 and Inspection ... - 2022 Jan 23
Salesforce Developer Controller
Hyderabad, Telangana, India
... •Experience in handling EQMS packages like Trackwise Digital and Complaints for customizing solutions to meet FDA requirements. •Experience in handling S2S integration to integrate with other salesforce systems, Lightning Communities. •Experience in ... - 2022 Jan 05
... •Experience in handling EQMS packages like Trackwise Digital and Complaints for customizing solutions to meet FDA requirements. •Experience in handling S2S integration to integrate with other salesforce systems, Lightning Communities. •Experience in ... - 2022 Jan 05
Software Analyst worked on OMS, PMS & FIX Protocol for 10+ Years
Hyderabad, Telangana, India
... Experienced in various modules of Fidessa - OMAR (Order management and routing), FDA (Fidessa Data Administrator), AMMA (Asia multi market access), IMAR (IOI Management and Routing), TMAR (Trade Management and routing). Experienced in DMA (Direct ... - 2021 Dec 27
... Experienced in various modules of Fidessa - OMAR (Order management and routing), FDA (Fidessa Data Administrator), AMMA (Asia multi market access), IMAR (IOI Management and Routing), TMAR (Trade Management and routing). Experienced in DMA (Direct ... - 2021 Dec 27
Associate statistical Programmer
Hyderabad, Telangana, India
... Good Comprehension of FDA and CDISC guidelines, International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline esp., E3, E6, E9 guidelines. Good Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP) ... - 2021 Jul 28
... Good Comprehension of FDA and CDISC guidelines, International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline esp., E3, E6, E9 guidelines. Good Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP) ... - 2021 Jul 28
Service Engineer Information Security
Hyderabad, Telangana, India
... Maintaining a rolling forecast for entire business IT needs Management of IT associated issues, risks and delivery including Lab IT Compliance & Validations as per various global pharmaceutical standards related with IT such as MHRA, FDA, EU, WHO ... - 2021 May 18
... Maintaining a rolling forecast for entire business IT needs Management of IT associated issues, risks and delivery including Lab IT Compliance & Validations as per various global pharmaceutical standards related with IT such as MHRA, FDA, EU, WHO ... - 2021 May 18
Medical Safety
Hyderabad, Telangana, India
... Preparing, summarizing, evaluating and documenting routine pre-SERM (Safety Evaluation Review Meeting) safety outputs from AZ dedicated safety database, dedicated external databases (FDA AERS, WHO Vigibase) and the published literature. ... - 2021 Apr 06
... Preparing, summarizing, evaluating and documenting routine pre-SERM (Safety Evaluation Review Meeting) safety outputs from AZ dedicated safety database, dedicated external databases (FDA AERS, WHO Vigibase) and the published literature. ... - 2021 Apr 06