Computer System validation Expert

4 weeks ago

Pune, India CO-WORKER TECHNOLOGY AB Full time
Computer System Validation Expert

Requirements:Pharma application areas:

Clinical domain, Pharmacovigilance domain and Manufacturing domain ( PV/Argus, CTMS applications, SaaS platform, AWS, manufacturing. QMS)

Experience level :Validation team – 5 years plus

Responsibilities:Partner with key business stakeholders to develop policies and procedures necessary to lead/guide the implementation and maintenance of a compliant, efficient, and integrated CSV program.Perform System Risk AssessmentCreate the end-to-end Validation Plan/StrategyReview Requirement Specifications including Regulatory & non-functional requirements.Review the Technical Design document and solution architecture.Perform Requirement Risk AssessmentAuthor Test PlanReview Pre-executed and post executed IQ, OQ and PQ ScriptsReview IQ/OQ/PQ Summary & Traceability MatrixCreate Validation Summary ReportManage Change ControlsPerform Periodic Review and manage CAPAProvide SME support on topics relevant to GxP, CSV, 21 CFR Part 11, Annex 11 etc.Qualifications:Bachelor's/master’s degree in engineering, Science, Medical or related field.Hands-on experience in Computer System Validation of Applications and Infrastructure Qualification.A minimum of 5-10 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).Strong working knowledge and experience of global regulations and guidelines such as GAMP, CFR Part 11 Annex 11 and other FDA regulations i.e. 21 CFR Part 210, 211, Part 820, ICH Q9, QSRs, ISO 13485, HIPPA etc. coupled with ability to practically apply such knowledge.Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions.

Preferred:Automation: Technical and understands GenAI, automate authoring process, reduction of 20% effort. Standard validation template, generate a plan. Providing more value.

Contact: Rekha for your next career move? Explore opportunities at co-workertech.com

  • Computer Systems Validation

    3 weeks ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    1 week ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    3 weeks ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    3 weeks ago

    pune, India TransPerfect Full time

    OVERVIEW The Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    3 weeks ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    1 week ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    2 weeks ago

    Pune, India TransPerfect Full time

    OVERVIEWThe Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • Computer Systems Validation

    1 week ago

    Pune, India TransPerfect Full time

    OVERVIEW The Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV...

  • System / PCIe Validation Engineer

    1 week ago

    Pune, India Ampere Full time

    DescriptionThe RoleThis position is for a System / PCIe Validation Engineer within the Silicon Validation Engineering team for Ampere’s best in class 64-bit ARMv8 Server Processor family. He / She has to run PCIe characterization and validation test cases of Ampere's state-of-the-art ARM server CPU for data-centers. You'll have the ability to learn quickly...

  • System / PCIe Validation Engineer

    3 weeks ago

    pune, India Ampere Full time

    Description The Role This position is for a System / PCIe Validation Engineer within the Silicon Validation Engineering team for Ampere’s best in class 64-bit ARMv8 Server Processor family. He / She has to run PCIe characterization and validation test cases of Ampere's state-of-the-art ARM server CPU for data-centers. You'll have the ability...

  • System / PCIe Validation Engineer

    1 week ago

    pune, India Ampere Full time

    Description The Role This position is for a System / PCIe Validation Engineer within the Silicon Validation Engineering team for Ampere’s best in class 64-bit ARMv8 Server Processor family. He / She has to run PCIe characterization and validation test cases of Ampere's state-of-the-art ARM server CPU for data-centers. You'll have the ability...

  • Matlab Validation Expert

    1 week ago

    Pune, India Source-Right Technologies Full time

    EXP: 2-6 yrs NOTE: Work from office LOCATION : Bangalore MATLAB Validation Experts (immediate joiners only) MANDATORY SKILLS Model Based Calibration,MATLAB,SIMULINK,MIL,SIL,TPT,TARGETLINK PREFERRED SKILLS C Programming concepts Experience in BCM domain (preferred), test cases, test specs 1. Good Implementation & Unit Testing skills (MIL/SIL) on...

  • Battery and Charging Systems Validation for a

    1 week ago

    Pune, India Skillventory Full time

    **Battery and Charging systems validation For a leading Auto OEM**: - From 6 to 7 year(s) of experience - ₹ Not Disclosed by Recruiter - Puneor **Roles and Responsibilities** **Job Role & Responsibilities** - Role: Validation of Battery and Charging systems in an Electric Vehicle_ - Technical/ Functional:_ - Responsible for validation of cells used in...

  • Battery & Charging System Validation For

    2 days ago

    Pune, India Skillventory Full time

    **Battery **&** Charging System Validation For**: - From 7 to 9 year(s) of experience - ₹ Not Disclosed by Recruiter - Puneor **Roles and Responsibilities** **Job Role & Responsibilities** - Responsible for validation of cells used in the battery pack. - This will include cell level characterisation and DVP of the cell - Pack level validation of...

  • Validator

    2 months ago

    Pune, India Siemens Full time

    Job Description: Validator Together we make the difference Siemens Mobility is an independent managed company of Siemens AG. Its core business includes rail vehicles, rail automation and electrification solutions, turnkey systems, intelligent road traffic technology and related services. The Information Technology (IT) department has the global...

  • Validator

    2 months ago

    Pune, India Siemens Digital Industries Software Full time

    Job Description: Validator Together we make the difference Siemens Mobility is an independent managed company of Siemens AG. Its core business includes rail vehicles, rail automation and electrification solutions, turnkey systems, intelligent road traffic technology and related services. The Information Technology (IT) department has the global...

  • Validation Specialist

    4 weeks ago

    Pune, India Wipro Full time

    Location:Pune/Bangalore Exp:7-10Y Job Description: Bachelor of Science in Computer Science, Computer Engineering, Electrical Engineering, or other related fields degree in computer science, Computer Engineering, Electrical Engineering, or other related fields preferred least 7 years of automotive system and component verification and validation...

  • Cybersecurity Validation Specialist

    2 months ago

    Pune, India Wipro Full time

    Location:Pune/BangaloreExp:7-10YJob Description:Bachelor of Science in Computer Science, Computer Engineering, Electrical Engineering, or other related fieldsdegree in computer science, Computer Engineering, Electrical Engineering, or other related fields preferredleast 7 years of automotive system and component verification and validation experienceyears of...

  • Cybersecurity Validation Specialist

    2 months ago

    Pune, India Wipro Full time

    Location:Pune/BangaloreExp:7-10YJob Description:Bachelor of Science in Computer Science, Computer Engineering, Electrical Engineering, or other related fieldsdegree in computer science, Computer Engineering, Electrical Engineering, or other related fields preferredleast 7 years of automotive system and component verification and validation experienceyears of...

  • L3 Vehicle Integration Validation and System

    2 months ago

    Pune, India Skillventory Full time

    **L3 Vehicle Integration validation and system verification**: - From 3 to 6 year(s) of experience - ₹ Not Disclosed by Recruiter - Puneor **Roles and Responsibilities** - Technical/ Functional:_ - Vehicle Integration and validation of EEE architecture in an electric vehicle. - CAN Log analysis and debugging of the vehicle during fault scenarios -...