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3.0 - 5.0 years

4 - 5 Lacs

Hyderabad, Madhapur, Telangana

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QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards . Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.) . Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects . Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions . Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40%

Posted 23 hours ago

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3.0 - 5.0 years

4 - 5 Lacs

Hyderabad, Madhapur, Telangana

Work from Office

Naukri logo

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana,

Posted 4 days ago

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3 - 5 years

4 - 5 Lacs

Hyderabad, Madhapur, Telangana

Work from Office

Naukri logo

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana, India

Posted 1 month ago

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6 - 10 years

10 - 12 Lacs

Manesar

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Dear Candidates, We have urgent opening for the position of Assistant Manager - Risk & Compliance in leading manufacturing company (Automotive) for Manesar location. Designation: Assistant Manager Profile: Risk & Compliance Location: Manesar Note: This position is for Corporate Office. Responsibilities:- Knowledge of ISO 27001 & NIST framework Working knowledge of conducting IT internal audit (ISMS, ITGC, ITAC, IFC etc.) Knowledge of information security policy & procedures. Knowledge of information security technologies (Firewall, SIEM, IAM, SOC, DLP, etc) Knowledge of regulatory requirements (IT act, Data privacy, etc) Good knowledge of Cybersecurity & Risk Management Knowledge of Project coordination If you are interested please share your updated cv at priya.pal@careernet.in Regards Priya Pal

Posted 1 month ago

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1 - 5 years

2 - 6 Lacs

Pune

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Job Description: QMS Executive Qualifications: Bachelor's degree in Computer Science, Information Technology, or related field. 1-3 years of relevant experience in Quality Management Systems (QMS). Preferred certifications: ISO 9001 Internal/Lead Auditor, ISO 27001 Internal/Lead Auditor. Skill Set: Knowledge of Quality Management Systems (QMS). Familiarity with ISO standards 9001 and 27001. Proficiency in reviewing/auditing internal projects and documentation. Exposure to Configuration Management Systems (e.g., SVN). Understanding of RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Action). Knowledge of software development methodologies. Excellent communication and documentation skills. Proficiency with MS Office tools. Responsibilities: Maintain and update document repositories related to QMS and ISMS. Ensure the master list of QMS documents is up-to-date. Support the QMO team in tasks assigned by the QMS Manager. Collect and analyze QMS-related data from project teams (e.g., best practices, metrics). Plan, execute, and report internal quality audits and track findings to closure. Review and suggest improvements for QMS/ISMS documentation. Assist in training coordination for Quality Management and ISMS. Support teams in implementing QMS processes during project lifecycle stages. Maintain records for customer feedback, CAPA management, and internal audits. Participate in Management Review Meetings (MRM) and monitor action item status. Coordinate with teams / departments during third-party audits and ensure compliance.

Posted 1 month ago

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