1476 Capa Jobs - Page 38

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparatio...

Role & responsibilities Responsible for managing and maintaining Quality Management System (QMS) activities within the Supply Chain Management (SCM) department, including Change Control, Deviation, and CAPA management. Ensures daily operations and documentation are in compliance with cGMP and regulatory standards. Supports audit readiness and continuous improvement initiatives within SCM.

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

Set quality benchmarks aligned with brand and buyer requirements. Ensure adherence to local and international compliance, safety, and testing standards. Develop and standardize inspection protocols (inline, mid-line, and final inspections). Ensure quality processes are integrated at every stage of production. Lead and manage the Quality Assurance and Quality Control teams across all production units and vendors. Conduct training sessions to improve the technical and inspection skills of the team. Conduct periodic performance evaluations and implement capability-building plans. Evaluate and approve vendors from a quality perspective. Work closely with production, merchandising, and sourcing t...

Execution of New Product Development from Input receipt to deposition within the given timelines Learn & Adapt Quickly to the Product Development Environment and be part of the development team Preparation of NP Calendar based on inputs from Brand Team, Innovation & strategic priorities. SKU level product-mix workout for NP budgeting. Understanding the complexity of the NP development and working out the appropriate timeline for the project. Tracking and monitoring of NP development status at Design/Development/Delivery stages. Understanding the manufacturing process and precise cost workout Sample development with both INH and Bought out Sources. Creation of Variant wise proto. Watch level ...

Should have in depth knowledge of ISO 9001, ISO14001, & ISO 45001 standards. Certified internal auditor / Lead Auditor will be an added advantage. Proficiency in GD&T and engineering drawing standards. Knowledge about manufacturing processes / work experience in chemical etching process , electroplating , mechanical stamping, furnace operations etc. Should have detailed knowledge on process validation , feasibility study and part qualification methods. Collaborate with CFT to support new part development , process improvement, and risk management. Sound knowledge of risk assessments, PRD, CP, FMEA, and RCA (5 Why, 8D problem solving, Fishbone Diagram, and Pareto Analysis). Ability to perform...

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Improve reliability of new product development processes Maintain company quality standard Review products, processes & systems on an ongoing basis to determine where improvement can be made Oversee the product manufacturing process to ensure quality Required Candidate profile Qualification: CIPET – PPT or BE/B.Tech Plastics/Polymers Experience: 10 to 12 years of experience in a relevant field.

Knowledge of relevant international codes and standards such as API, ASME, NFPA, CAP437 Working experience of E3D & SP3D software experience in Oil & gas in offshore projects. Capability of developing and checking above mentioned key deliverables.

Skill required: Marketing Operations - Quality Management Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketin...

Company Name : Japanese MNC (NIDEC INDIA PVT LTD.) Nidec India is a Japanese MNC and one of the leading Motor manufacturers serving the Automotive, EV and Home appliances' industry. Its Neemrana plant is the first independent plant of India. It is a part of Nidec Group which has a Global network with more than 300 Companies in more than 45 Countries. Location : Neemrana Qualification : B.Tech-Electrical /Mechanical Experience : Min 4 Years of experience. Designation : Sr. Engineer Department : Quality ***********(MANDATORY)************* Conduct customer audits, APQP, PPAP documentation, MSA, SPC, IATF, 7QC tools, CAPA activities to ensure quality standards are met. Additional Preference : If...

The Senior Executive QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering chan...

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct interna...

Key Responsibilities: -Develop, manage, implement, communicate, and maintain a quality plan to ensure the company's Quality Assurance Systems and Policies align with quality system requirements. -Collaborate effectively with the Technical, Development, and Production teams to maintain and ensure product quality standards. -Oversee the maintenance of all necessary documentation, including Quality SOPs (Standard Operating Procedures). -Ensure adherence to sustainability and factory compliance procedures, including certifications like GOTS, GRS, OCS, BCI, etc. -Maintain proper record-keeping for sustainability initiatives and relevant certifications. -Develop inspection methods and strategies t...

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same. Key Responsibilities Be a part of core project team and support the quality engineering across the entire development cycle Participate in product risk management, usability, reliability and design...

Skills: Oracle Database, Postgres, Database design Secondary Skills: Data modelling, Performance Tuning, ETL processes, Automating Backup and Purging Processes Skill Justification Database Designing, Data Modelling, and Core Component Implementation: These are fundamental skills for a DBA. Database designing involves creating the structure of the database, data modelling is about defining how data is stored, accessed, and related, and core component implementation ensures that the database is set up correctly and efficiently. Data Integration and Relational Data Modelling: Data integration is crucial for combining data from different sources into a unified view, which is essential for accura...

Key Skills: Troubleshooting & Diagnostics Breakdown Maintenance Preventive maintenance Open Die Hydraulic press Electrical Maintenance (Electrical expertise preferred) Strong knowledge of Siemens PLC, Drives, HMI & programming software. Knowledge of HT power line distributions, familiar with ACB, VCB & other switchgears Root Cause Analysis, CAPA TPM ISO Documentation Requirements: 5+ years of experience in open die press service and maintenance. Electrical Engineering (Degree or Diploma). Strong understanding of open die press principles and processes. Excellent communication and interpersonal skills. Ability to work both independently and as part of a team. Proficiency in HANA (SAP) & compu...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. ...

EDUCATIONAL QUALIFICATION Diploma - Electrical MINIMUM YEARS OF EXP – 3 to 7 Years NATURE OF EXPERIENCE Experience of working in continuous process industry and shifts. Good technical knowledge of process industry electrical equipment’s. Good knowledge in trouble shooting Knowledge in Industrial Safety, 5S, ISO Systems Knowledge on Electrical Maintenance activities Knowledge about earthing concepts and basic operation of AC Drives/ Servo Control, PLCs, SCADA SPECIFIC SKILLS/PERSONAL ATTRIBUTES Pro-active, result-oriented and possess analytical skills Detail Oriented Manpower management. Team Player Emergency handling & Crisis management Problem Solving attitude Working with cross-functional ...

Quality Assurance Engineer Job Title : Quality Assurance Engineer Location : Chennai, Hyderabad, Bangalore Experience : 0-2 Responsibilities : Design, implement, and monitorquality control systems and inspection proceduresto ensure product compliance with specifications and standards. Conductin-process and final product inspections, using tools such as calipers, micrometers, and CMMs. Leadroot cause analysis and corrective/preventive actions (CAPA)for quality issues and customer complaints. Collaborate with cross-functional teams to supportAPQP, PPAP, and FMEAactivities during new product development. Maintain and updatequality documentation, including control plans, inspection reports, and ...

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitt...