6070 Qms Jobs

Requirement of following candidates: 1) B. Pharm/ M. Pharm - for production, QA (male candidates preferred) 2) B.Sc/ M.sc - for QC (male/ female both preferred ) 3) B. tech/ M. Tech - for engineering (only male candidates)

Experienced QA professional for medical device (IOL) manufacturing. Must have strong knowledge of ISO 13485, CE certification, and international regulatory standards. Experience in documentation, audits, and device licensing preferred. Required Candidate profile Candidates with 0–5 yrs QA experience, hands-on with audits, documentation & regulatory submissions.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessfu...

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessfu...

Experienced in independent instrumental analysis of raw material, in process samples, finished product and stability samples of pharmaceutical products. Well versed in analysis of Tablets, capsules, liquids samples, for common test as Assay, Related substances, Dissolution and preservative content analysis as per controlled specification and method of analysis. Should able to operate, calibrate and maintain instruments like HPLC, GC, Dissolution apparatus, UV and FTIR etc. Experience of Empower, Lab solution software shall be recommended. Exposure to perform AMV or development shall be preferred. Aware about on line & good documentation practices. vii. Should have knowledge of Data integrity...

Lead the selection, specification (URS), configuration, and deployment of the ERP system (SAP or equivalent) Ensure system validation and data integrity in line with GMP/GDP principles Coordinate integration between ERP & other site systems Required Candidate profile Proven knowledge of GMP Data Integrity and GAMP 5 validation standards Strong expertise in ERP systems (SAP, Oracle, or Sage X3) & integration with LIMS, QMS, MES

Production - Senior Officer -Fermentation upstream opertor. Should have experience in Aseptic practices, Handling of Fermenter, Process vessels, Homogenizer, TFF systems, Filtration, Biosafety cabinet. Microbial fermentation experience. Manufacturing activities according to effective SOPs. Batch related documents in manufacturing area. Readiness related to batch manufacturing. Execution of activities in compliance to cGMP. Execution of activities during campaign change. Decontamination and disposable of bio waste. Preparation of URS for the equipment. Preparation of MCB/WCB. Automated or manual CIP of all the equipment in the manufacturing area. Follow safety norms in the manufacturing depar...

Division Department Sub Department 1 Job Purpose Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute production activities in a shift by managing available resources to achieve production target Execute assigned tasks as per planned production activity to meet production targets for a shift Regulate usage of consumables in the production process at optimum levels to save costs Increase the efficiency of area by utilization of equipment and by reducing downtime in manufacturing area Key Accountabilities (2/6) Maintain standard process parameters as per BMRs and other sup...

To ensure GMP compliance to approved procedures / practices as per SOP. Responsible for review of analytical records, handling of QMS related activities for Quality control.Ensure compliance for Quality Control. Required Candidate profile Male candidate prefers Vasai-Virar, Palghar location.

As a Veeva QMS Solution Architect at Cyient, you will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform. Your key responsibilities will include: - Supporting all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team. - Coordinating with Business analysts to outline the business requirements and ensure IT security and Data Integrity requirements are outlined for the solution. - Coordinating with Validation team to prepare the Regulatory Applicability Assessment and Regulatory Risk Assessment documents. - Documenting speci...

Job Description You will be responsible for overseeing quality assurance processes as a Manager - Quality Assurance (QA) at ZIM Laboratories Limited located in Nagpur. Your role will involve ensuring adherence to regulatory and compliance standards, implementing strategies to maintain product quality, reviewing and approving quality documentation, managing QA audits, supervising quality control operations, and coordinating with R&D and production teams to uphold quality benchmarks. Key Responsibilities - Oversee quality assurance processes - Ensure adherence to regulatory and compliance standards - Implement strategies to maintain product quality - Review and approve quality documentation - ...

As a Technical Configuration and System Integration Specialist, your role involves configuring Veeva Vault modules to meet business requirements and ensuring system validation. Additionally, you will be responsible for document management and system administration, specifically focusing on Quality Docs and Electronic Document Management System (EDMS). Key Responsibilities: - Administer and maintain Veeva Vault DMS, including Quality Docs and other modules. - Configure Vault modules such as Quality Docs, QMS, RIM, Promo Mats, and eTMF. - Oversee the document lifecycle from creation to archiving in compliance with GxP and quality standards. - Maintain version control, metadata, and audit readi...

JOB DESCRIPTION: Primary Job Function: Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures. Monitor compliance of Loan license manufacturing sites and TPMs. Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures. Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs. Review ongoing stability data and control samples of Abbott products. Ensure implementation of Abbott quality audit CAPA & closure at LLMs. Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check. Coordinate with resp...

Hendrick Motorsports Technical Solutions Location: 4400 Papa Joe Hendrick Blvd, Charlotte, North Carolina 28262 We are seeking a detail-oriented and experienced quality engineer to join our operational excellence team in Concord, NC. The role will be responsible for coordinating and executing the Production Part Approval Process (PPAP) to ensure that components meet customer requirements and internal quality standards. This role plays a critical part in new product development, quality management, and continuous improvement initiatives. Key Responsibilities Lead and manage PPAP submissions in accordance with AIAG standards and customer-specific requirements. Work with supplier quality engine...

Administer the documentation lifecycle as directed, These include all QMS and transitioning documents such as drawings, policies, processes, procedures, work instructions, forms & templates. Required Candidate profile Exp. with Document Control software Exp. or familiar with ISO 9001 Standard, SolidWorks PDM, Infor SyteLine or other ERP systems preferred Manufacturing, Quality or Document Control exp. preferred

Develop, deploy & administer Document Management Exp of working with or developing workflows for a PDM/PLM system to troubleshoot, maintain, monitor, report & advise on core systems including workflows, approvals Required Candidate profile 6-Sigma Yellow/Green Belt certification preferred Deep understanding of MS Office 365 Apps (VBA and Macros SQL database development knowledge. A strong understanding of ISO Standards is expected.

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Spring Boot Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications are aligned with business objectives. You will also engage in problem-sol...

Responsibilities: * Develop & implement quality processes * Ensure compliance with CIPET standards * Manage QMS documentation * Collaborate on mechanical engineering projects * Maintain quality system management

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Spring Boot Good to have skills : NA Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly to support business objectives. You will engage in problem-solving discussions and contribute innovative ideas ...

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessfu...

About The Role Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. ? Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successfu...

Qualification and Experience required: Postgraduation with MSW/MPH/MBA with minimum 03 years of experience in health- related projects at districts/state level Desirable skills: Proficient in MS Office Knowledge of development principles, development sector landscape and technical sector updates Building successful collaborative relationship with internal and external stakeholders Experience of working with National health program in a managerial capacity will be preferred Experience in lab related projects will be preferred Well familiar with public health programs in India Good coordination skills Good oral and written communication skills Strong team orientation Nature of Appointment:The ...

Analyzes and interprets the payment terms and conditions of fully executed site clinical trial agreement (CTA). Ensures accuracy of contract budget & clinical trial management system (CTMS) template alignment. Performs medium to complex weekly target of 35 CTA budget setups within CTMS, and maintains support of 100+ sites. Inputs site budget cost utilizing the t emplates within CTMS. Engages project team with the quality control of the cost structure created within CTMS. Serves as subject matter expert for department & project teams concerning contract interpretation and development of payment strategy. Ensures the presence of required vendor, participating in clinical trial, financial accou...

Position Summary The Business FP&A Manager should acts as the primary finance partner to key business functions, providing financial insight, performance management, and strategic decision support. This role goes beyond reporting "” it drives financial accountability, supports growth initiatives, and is aligned to business priorities. Job Responsibilities Business Partnering Partner with business leaders to plan and review revenue, margins, forecasts, and critical financial metrics Planning & Forecasting Work with multiple stake holders on revenue forecasting process. One should be able to analyze and pro-actively highlight the risk/opportunities on projected numbers One should be able to pl...

QA Documentation Validation / Qualification Documents Control and Archival of documents Retain Sample Handling and Observation SOP Preparation and Revision related Activities BMR Preparation and Review Monitoring of all the QA activities, test results, leaked defects, and identifying areas of improvement. Handling of QMS Related Activities (change control, deviation, Market Complaint, incident, OOS). Knowledge of regulatory guidelines and requirements, such as FDA, MHRA, and ICH & ISO Standard.