833 Capa Jobs - Page 11

Job Title: Quality Assurance Executive Location: Bhiwandi Company: Vistaprint India Reports to: Quality Manager Job Summary: Responsible for implementing and maintaining quality systems on the shop floor, ensuring FOA/CTQ processes, conducting inspections, managing a team of quality inspectors, and driving continuous improvement. Will handle in-process/customer complaints, perform root cause analysis, and ensure compliance with QMS, SOPs, and ISO standards. Key Requirements: 48 years of QA experience in a printing/manufacturing setup Knowledge of FOA, CTQ, QMS, ISO, 5S, RCA, and quality tools Strong team management & documentation skills Diploma/Degree in Mechanical or Printing Technology Flexible to work in shifts Facilities: Bus & Canteen provided

Role & responsibilities Job Description: 1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOP’s related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipment’s. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipment’s in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer. Preferred candidate profile ITI/ DIPLOMA/ B. TECH/ Pharmacy With Relevant experience

Requirement Injectable and Ophthalmic R&D. Department: Development QA. In Complex injectable and ophthalmic drug products for regulated market Total Experience required - 10 to 14 years Qualification: M.Pharm Job Location:- R&D, Rau, Indore, M.P Company: Knovea pharmaceutical, Pvt. Ltd Below is the Job description for the DQA position, To participate and execute the quality management system for R&D centre. To participate & ensure the documents issuance, retrieval, archival and obsoletion of documents. To facilitate quality culture, good documentation practices for R&D related activities. To develop training modules and organize and conduct training sessions for R&D functions. To maintain and execute Quality Management System related to (Change control, Incidents, CAPA, Effectiveness review, Calibration management) Assigning project and document numbering for R&D projects as applicable. Review and approval of protocols/reports for Equipment/instrument Qualification, Stability studies or any product related studies etc. Standard operating procedures (SOP) preparation/review/approval/distribution and archival. Issuance of calibration formats/annexures, SOPs, Specifications/MOA, Equipment/Instrument logbooks and other controlled documents to user. To ensure compliance for calibration/PM & instrument qualification activity in Analytical and Formulation Labs for R&D. To review and approve the technology transfer document and product development report/specification and other technical documents etc. for R&D. To plan and conduct the Internal Audits and act as a facilitator for External Audits for R&D. Ensure compliance for current SOPs, policies, and ICH guidelines and country specific regulatory requirements. Proficient in Microsoft Office (Excel, Word, Outlook & Teams) is an added advantage. Note : AQA/Lab QA experience in Ophthalmics/Injectables can also apply. Interested candidates can DM me and share a CV dipesh.dey@knovea.com,

Responsibilities: * Conduct quality control checks on electrical components. * Participate in process improvements through CAPA implementation. * Collaborate with ITIs for training programs.

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

Long Description 1 Exposure of execution of planning of Inprocess, Finished product, stability and cleaning validation samples of MDI / DPI formulation. 2 Exposure of compliance to all cGMP, GxP or any other regulatory requirements, including EHS requirements. 3 Maintenance of GLP in the Laboratory. 4 Having knowledge of Analytical Instruments like HPLC, GC, GCMS, LCMS, UV, IR, KF, ACI, NGI, DUSA, Spray Pattern etc. 5 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation, CAPA, Change control etc. 6 Exposure of Stability sample management & Regulatory Audits. 7 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 8 Exposure of Calibration of Analytical Instruments & Equipment’s 9 Compliance to observation noted during internal and external audits. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Graduation in Pharmacy Work Experience 10 to 15 years.

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

Witnessing of manufacturing process (mixing, granulation, blending, compression, coating, capsule filling) & packing (primary/secondary packaging) for solid oral products to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory expectations. Oversight of line clearance, equipment and area cleanliness, material verification, and adherence to SOPs. Ensure compliance with data integrity (ALCOA++) standards in all documentation and records related to production and QA oversight. Review of batch documentation to ensure product quality and regulatory compliance. Review of unplanned deviations and CAPA. Review of environmental monitoring data Collaborate with site operations and quality functions to report and ensure resolution of non-conformances or compliance gaps.

Long Description Role- Shift Officer - MDI Manufacturing To Supervise compliance to all CGMP or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on relevant SOP. Report any quality concerns or suggestion for improvements SOPs. Execute and supervise all tasks and activities as per the applicable SOPs. Supervision of operations, cleaning and maintenance of MDI process equipment's / area in MDI Production area of unit-3. Planning, execution, monitoring supervision of all unit operation for batch processing and Manufacturing. Co-ordination with cross-functional teams for smooth execution of production plan at shop floor. To ensure documentation of required process parameter as per SOPs. Training and development of subordinates to ensure functioning at shop floor as per cGMP requirements. To ensure status labelling of equipment, machines, area and instruments comply with the requirements. In-process checks during stage wise process as per Batch Manufacturing Record as per Standard Operating Procedure. Gap analysis of defined procedures in BMR / SOP / Protocol and initiation of corrective action. Handling of Quality Management Documents like change control, deviation, CAPA and other related documents. To ensure required inventory of approved consumables in Warehouse. To report of incident, non-conformity immediately to the manager. Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management Education Work Experience

About The Role 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 marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designAct of overseeing all activities and tasks needed to maintain a desired level of excellence. This may include the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. What are we looking for Ability to work well in a teamAdaptable and flexibleCommitment to qualityWritten and verbal communicationAgility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Long Description Annual maintenance contract preparation and preventive maintenance of QC instrument as per approved procedure. Breakdown handling of QC instrument as per approved procedure. Upkeep the records for preventive maintenance and breakdown in SAP. Qualification of New instruments with complete documentation. To participate in failure investigations related to instrument malfunctions. To impart training to the analysts for instrument maintenance and troubleshooting. Co-ordination with service engineer for service/ breakdown related activities To maintain good laboratory practices and discipline in respective work area. Actively taking part in cGMP, training and SOP training as and when required. Supporting for calibration and validation activity of Thermolab Make instruments. Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence Education Graduation in Instrumentation Work Experience 5 to 7 years

PureSoftware is looking for L2 Application Support Professional to join our dynamic team and embark on a rewarding career journey Provide second-level support for business-critical applications by diagnosing and resolving incidents, service requests, and technical issues escalated from L1 support Monitor application performance, system logs, and alerts to proactively identify potential problems and ensure system stability Collaborate with development, infrastructure, and third-party vendors to troubleshoot and resolve complex application issues Perform root cause analysis (RCA) for recurring issues and recommend permanent fixes to improve system reliability Manage user access, configuration changes, and minor enhancements while ensuring adherence to change management policies

Education Graduation in Pharmacy Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Work Experience 3-6 years work experience in Fette compression machine

Alembic Group is looking for Manager - Quality Control to join our dynamic team and embark on a rewarding career journey A QC Manager is responsible for managing the quality control process within a company or organization They oversee the quality assurance procedures for products, services, and processes to ensure they meet the required standards and specifications The QC Manager must be skilled in analyzing data, identifying trends, and implementing corrective actions to improve quality control Develop, implement, and maintain quality control policies and procedures Establish quality control metrics and benchmarks to monitor product and service quality Develop and oversee quality control inspection and testing procedures Analyze quality control data and trends to identify areas for improvement Develop and implement corrective actions to improve quality control processes Ensure compliance with industry standards and regulatory requirements

Key Responsibilities Process Improvement & Automation Identify repetitive and manual processes ripe for automation across reporting, documentation, and administrative workflows Lead initiatives to streamline operational tasks and improve capacity management Collaborate with cross-functional teams to implement scalable efficiency solutions Reporting & Analytics Own monthly reporting cycles, including dashboards, benchmarking, and methodology-based tracking Proactively refine reporting methods for better transparency and time savings Document & Site Management Maintain and manage SharePoint and Sphere sites, including user permissions, file structures, and content consistency Support migration planning and execution from legacy platforms (Box) to MyDocs (DocShare) Policy Alignment Cycles (PAC) Coordinate PAC verification and documentation efforts twice annually, ensuring change-tracking and comment logging are consistent Business Impact Assessment (BIA) Support Verify and update application lists and organizational structures by location Ensure data integrity and audit-readiness of structured documentation Required Skills & Qualifications Strong eye for identifying automation opportunities and driving operational efficiency Highly organized, detail-oriented, and independently driven Familiarity with platforms like SharePoint, DocShare, Sphere, and other enterprise documentation tools Competence in reporting tools and dashboard creation (Excel, Power BI preferred) Excellent communication and collaboration skills

Role & responsibilities Personality Traits: Strong leadership and decision making abilities Excellent problem solving and analytical skills Ability to handle customer concerns and audits effectively Detail oriented with strong process improvement focus Strong communication, coordination, and interpersonal skills Preferred candidate profile Work Experience: 8+ years of experience in quality management within a manufacturing environment, Strong knowledge of ISO standards, IATF 16949, and customer specific quality requirements, Experience in handling internal, customer, and third party audits, Leadership experience in managing quality teams

As a qualified candidate with a BTech degree in Computer Science or Electronics & Communication and 1 to 2 years of experience, you will be responsible for the following key tasks: Product Inspection & Testing: - You will be required to perform validation and verification testing to ensure the consistency of products. - Investigate and effectively resolve any quality issues or defects that may arise during the testing process. - Maintain detailed test records and generate quality reports to track and communicate the outcomes of the testing procedures. - Analyze the root causes of quality failures and implement appropriate corrective actions to address them effectively. Customer Complaint Handling & CAPA (Corrective and Preventive Actions): - Conduct thorough investigations into customer complaints and non-conformance issues to identify areas of improvement. - Develop and implement CAPA processes to proactively address and prevent recurring quality issues, ensuring continuous enhancement of product quality. - Collaborate closely with cross-functional teams to enhance customer satisfaction levels by addressing feedback and implementing necessary improvements. Your role will be crucial in ensuring the quality and consistency of products through meticulous testing procedures and efficient handling of customer complaints, ultimately contributing to the overall success and reputation of the organization.,

As a Production Manager, you will be responsible for overseeing and managing day-to-day production operations to ensure quality, cost efficiency, and on-time delivery of products. You will develop and implement production schedules while ensuring compliance with Good Manufacturing Practices (GMP) and USFDA regulations. Your role will involve maintaining regulatory compliance with USFDA, WHO, and other standards, coordinating with the Quality Assurance (QA) team for audits, and ensuring proper documentation of manufacturing processes. Leading and mentoring the production team will be a key aspect of your job to drive optimal performance and regulatory awareness. You will be expected to foster a culture of continuous improvement, accountability, and teamwork. Identifying and implementing process optimizations to enhance productivity, efficiency, and quality will be essential. Collaboration with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain will be required to address production-related issues effectively. In terms of equipment and facility management, you will need to ensure proper maintenance and calibration of production equipment and facilities. Implementing safety protocols to uphold a hazard-free work environment is crucial. Resource planning will also be part of your responsibilities, involving managing raw material inventory and maintaining uninterrupted production. You will also be tasked with preparing and managing the production budget to optimize costs without compromising quality. For this role, a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field is required. A minimum of 5-7 years of experience in pharmaceutical manufacturing in a managerial capacity is necessary, along with a proven track record in USFDA-regulated environments and knowledge of cGMP, CAPA, and regulatory submissions. Your technical skills should include a strong understanding of pharmaceutical production processes, familiarity with validation protocols, exceptional leadership and communication skills, as well as strong analytical and problem-solving abilities. The ability to work under pressure, meet tight deadlines, and collaborate effectively with various teams will be critical to your success in this role.,

Must have contributed to Customer Audit (Maruti VSA System) Inspect incoming materials, raw components, and in-process products Monitor manufacturing processes, Data inspections, testing,trends, patterns,potential quality PPAP Experience is must. Required Candidate profile knowledge of PPAP, MSA, SPC, CAPA, PFMEA mandate Investigate quality issues, identify root causes, and implement corrective and preventive actions to prevent future defect fasteners,screws,bolts know

1.As per QMS, implement, and maintain process controls and procedures 2.Identify, analyze, and resolve process-related quality issues through root cause analysis techniques (Fishbone, 5 Whys, FMEA 3.Work with cross-functional teams to identify CAPA Required Candidate profile 7. Conduct layout, process and product audits, report compilation and reporting. 8. Knowledge of GD&T. 3. Utilize (SPC, Control Charts) to track process stability and capability.

Initiation, review and approval of all types of quality management systems (Ex: Change controls, Deviations, Investigations, CAPA, OOS, and Complaints etc.) Handling of Return Goods. Handling of quality system and perform risk assessment to the required quality system. Conduct regular internal audits as per the need basis. Reviewing and approving of all documents (SOPs, Spec & STPs, Forms, protocols and reports etc.) Review of annual product quality review reports. Providing training on all cGMP topics to employees at site. Supporting to customer audits/ visits and regulatory audits. Support to provide necessary documents for amendments, annual updates and regulatory filings and CMC supporting documentation. Filling of questionnaires, declarations & quality agreements. Execution of additional responsibilities assigned by HO

• Follow up with supplier for Quality documents required as per IS standard. • Performed root cause analysis to identify and resolve defects with the help of ,Ishikawa, 7QC,8D, Why-Why analysis. • Conducting meeting with supplier for CAPA to reduce overall rejection. • Timely coordination with supplier ,Internally sharing rejection report, queries regarding test certificate . • Prepare Quality Assurance Plane (QAP) as per scope of work. • Inspection of Pre & Post fabrication activity. • Preparation of Welding procedure Specification (WPS,WPQR,WPQ) • Handling all measuring instrument as well as Tachometer, Sound level, Vibration measuring Instruments. • Conduct FAT with the customers to get the acceptance before delivery . • Vender inspection, Coordinating third party inspection agency, Prepared MOM with clients. • Incoming material Inspection ,Stage Inspection, Final Inspection prepared all documents as per ISO,API and ASME standard. • Coordinating and Guide at the time of final Inspection with Client . • Attend ISO9001:2008,ISO9001:2015Internal And External Audit

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR To carry out CIP & SIP of the vessels related to compounding and flitration area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder Preparation and periodic revision of SOPs related to compounding area. Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering, HR and administration for the day to day activities. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

knowledge of GMP guidelines, CAPA, deviations, change control. Handling SOPs, batch records, validation protocols, audits, regulatory inspections, aseptic practices. Equipment, process, cleaning, and method validation expertise.

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others