446 Capa Jobs - Page 18

Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab

QA & QC Executive Job Description Position Overview The QA & QC Executive is responsible for ensuring that products meet quality standards and regulatory requirements through systematic inspections, testing, and process monitoring. This role involves collaboration with production teams to implement corrective actions and continuous improvement initiatives. Key Responsibilities Quality Control & Inspection Conduct inspections on raw materials, in-process products, and finished goods to identify defects or deviations from quality standards. Utilize measurement tools and testing instruments to verify dimensions and other quality criteria. Monitor all operations that affect quality and report malfunctions to production executives to ensure immediate action . Quality Assurance Procedures Develop, implement, and maintain quality control procedures, ensuring compliance with established standards. Ensure that manufacturing processes meet safety, regulatory, and industry-specific standards. Identify potential risks and quality issues, proposing solutions and improvements to prevent recurrence . Documentation & Reporting Prepare and maintain quality documentation, including inspection reports, quality control records, and audit findings. Analyze quality data and metrics to identify trends and areas for improvement. Ensure all quality-related documentation complies with industry regulations and is readily accessible for audits or inspections . Training & Collaboration Train and educate employees on quality control procedures and standards. Collaborate with production teams to address quality concerns and implement corrective actions. Provide technical support to production teams on resolving quality-related issues . Continuous Improvement Participate in root cause analysis for recurring quality issues and recommend solutions. Suggest new techniques or technologies to improve product quality and efficiency. Lead initiatives aimed at improving quality standards, efficiency, and cost-effectiveness in the manufacturing process . Qualifications Education : Bachelor's degree in Engineering, Manufacturing, Industrial Technology, or a related field. Experience : Minimum 1–3 years in a quality control or assurance role within a manufacturing or relevant industry. Knowledge : Familiarity with quality management systems (e.g., ISO 9001, ISO 22000, HACCP) and industry-specific standards. Skills : Strong analytical, problem-solving, and communication skills; proficiency with quality control tools and techniques. Ideal Candidate Profile Detail-oriented with a strong commitment to quality standards. Proactive in identifying and resolving quality issues. Effective communicator and team player. Adaptable to dynamic manufacturing environments.

Awareness of measuring instruments. Good communication written & mail communication skills. Awareness of drawing & inspection / testing. Knowledge of SAP & system. Analytical thinking & problem solving.

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of sterilized garments, materials, and equipment in aseptic areas. Raise deviations, non-conformances, and change controls as needed. Assist in investigations for OOS, OOT, or any batch-related quality issues. Provide training to operators and workers on GMP, GDP, and aseptic technique

Roles and Responsibilities Conduct call audits to ensure quality standards are met. Perform root cause analysis (RCA) on non-conformances identified during audits. Implement corrective actions (CAPA) to address quality issues. Utilize QC tools such as Pareto Analysis, Call Calibration, and 7QC to improve process efficiency. Collaborate with team members to maintain high-quality processes. Desired Candidate Profile 4-9 years of experience in Quality Management or related field. Strong understanding of Quality Control principles and practices. Proficiency in performing Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA), and other Quality Tools like Pareto Analysis, Call Calibration, 7QC etc.

Role & responsibilities - To Monitor Working of Quality Department Incoming, In process, Outgoing. - To ensure timely completion of new projects for customers - To control process sheets and process changes - To audit working of quality department - To monitor statistical process control - Raw material / product development sample management Verification - Carry out and monitor quality and cost improvement initiatives - Responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems - To ensure the customer requirements are met - Conduct Internal Quality Non- Conformance Review - IATF -16949 audit certification renewal - Secondary supplier status analysis - FMEA, APQP, Incoming Inspection, Internal& External Failure Verification - New product and New development report with management approval - Evaluating NC point & Countermeasure submission to the customer - Maintain the mixing ration history for tracking - Verification. - Existing and new raw material MSDS report – Validation - New raw material supplier 4M changes report reviewed Preferred candidate profile - Customer specification test standard – Validation - DQC will be checked on weekly & monthly - Improve the product quality analysis report verification and implementation. - Zero Rejection - verification of daily production product. - Quality tracking system verification. - Basic Lot Test & Long-term Test Result - Validation. - Incoming RM /Product Improvement status analysis - Inward Inspection report - Validation. - Daily production test - Result validation. - Product Revalidation report – Review - Lot Test report for each product – Review - Existing product improvement result Review - Line problem and customer improvement analysis - Customer Quality audit support. Perks and benefits Yearly Bonus: Twice in a Year (120% on Gross) Travel Facility: Gummidipoondi to Madhavaram Food Allowance: Free of cost twice per day Special Allowances: Benefits for marriage, new born babies & other scenarios. Accommodation: Provide free Accommodation for Bachelors Other Benefits: PF, ESI & Group Medical Insurance.

Responsible for all production related responsibility, Ensuring & monitoring daily production process of all deptt. FRP, Rework,Tape, Flex,LFT, Ensuring that all the CAPA of non-conformities found are implemented, Manpower controlling staff & workers Required Candidate profile BE / BTech - Automobile or Mechanical having 10+ years of work experience Knowledge of ISO documentations, CAPA Leadership, technical, and interpersonal skills Ability to manage people & resources

Key Responsibilities: Operate, monitor, and maintain Lyophilizers, HVAC systems, chillers, and AHUs to ensure efficient functioning. Perform routine and emergency maintenance tasks, ensuring minimal downtime and optimal performance of equipment. Maintain accurate operational records and detailed maintenance logs for all equipment. Ensure adherence to cGMP (current Good Manufacturing Practices) and cleanroom standards in daily operations. Follow Quality Management System (QMS) protocols, including SOPs (Standard Operating Procedures), change control, and Corrective and Preventive Actions (CAPA). Troubleshoot equipment issues and implement effective solutions to prevent recurrence. Conduct equipment qualification and requalification processes to ensure compliance with regulatory requirements. Collaborate closely with cross-functional teams and leadership to meet production and operational goals. Job Location: Bus transportation facility available from Ahmedabad, Kalol & Kadi. Education Qualification: I.T.I Fitter

Quality Sr Mgr for Heavy fabrication industry Proper welding, Painting & PDI ,QMS through the implementation of good build-in quality and inspection system. team lead role heavy Engineering like construction & Mining equipment manufacturing company Required Candidate profile BE Mechanical with 20 to 25 year of experience heavy fabrication Responsible for welding document preparation like WPS, PQR, WPQ, Welder Continuity records, welder training records, etc. CAPA, Hindi

Ensure contractor compliance with GMP and regulatory standards.Conduct audits and inspections of contractors, manufacturers, and suppliers.Review and approve Batch Records, SOPs, and quality documents. Required Candidate profile Manage deviations, CAPA, and ensure timely corrective actions. Liaise between contractors and internal teams for smooth operations.

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

About The Role ResponsiblefortheImplementation,executionandmonitoringofInternalaudits,RiskManagement, Client audits & compliances, IT Governance audits, Vendor audits,Information security incident management and Information security training andawarenessintheorganization RepresentorganizationduringExternal/Clientaudits Provide guidance and global perspective to the development and annual updating ofinformationsecuritypolicies,standards,baselines,andproceduresandalignthemwithISO27001 standards, Security / data privacyregulation andbestpractices followed inthe industry Responsible to develop Internal audit plan for the year and monitoring and tracking theidentifiedgapstill closures Preparingauditchecklistandauditreport Performing risk assessments of functions, processes, infrastructure, and facilities whichincludes identifying threats, vulnerabilities, and compensation controls developing a riskprofile for the assessed environment, and developing a risk reduction plan for theenvironment Understand client compliance requirements affecting and required for informationsecurity, ensure related compliance requirements are being met and provide compliancereportingartifacts insupportofregulatory exams ProofreadingoftheclientMSAandextractinginformationsecurityrequirementsfromitandcommunicatingittotherelevantstakeholderforthecommission ofbusinesssetup ScrubbingMSAtoidentifytheauditableareaandtoprepareauditablechecklistfromit Continuousmonitoringofclientcompliancesbyconductingvariousinternalauditandgovernance activities giving guidance and forming checklist for the team to carry outtheseactivates Conductingthevendoraudits Conductingorientation&trainingprogramsandpresentinginformation security awareness to new joiners and taking refresher training for theexistingemployeestomeetorganizationsecurity posture Promoteawarenessintheorganizationthroughmailers,screensavers,puttingupposters, conducingquizetc. Identifying and driving new Information Security projects that help in improving information security posture in the organization

About The Role Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction ? Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPO’s defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality team’s intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption ? Deliver No. Performance Parameter Measure 1. Quality Standards Timely generation of reports, dashboards, insights to the respective team Accuracy of the data Feedback from the project teams on the insights Quality of insights shared with the team ? ? Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Responsible for planning and execution of API and intermediates according to pre-approved instructions and raw materials, manpower according to the requirementResponsible for prepare, approve, improvement, continuous review and upgradation of existing production SOPs.Responsible for change controls, deviations / OOS / complaint / OOT, validations, qualifications, calibrations and investigations and evaluations. Trainings and implementing cGMP & Safety, Hygiene in production areas. Responsible for handling of Spray dryer and Homogenizer.Facing the customer audits, regulatory audits and conducting self inspections inter departments New product introduce in the plant and establishment the process for commercial with the help of R & D. Review of technology transfer documents related to production and implement accordinglyResponsible to ensure material handling without spillage and to protect product and deterioration.Involvement in quarterly and Annual product quality review.To Conduct, HAZAOP and Risk assessment of product, system, equipment, item, process as per standard procedure.Ensure Strict adherence to safety, health & environment.Ensure Data integrity

Role & responsibilities To carry out investigations related to OOS, OOT, Incident and Extraneous Peaks to ensure their closure and implementation of CAPA. Responsible for execution of Regulatory Notification as per SOP. To ensure implementation of all proposed actions identified as a CAPA of investigations related to OOS, OOT, and incident. Review of investigation reports, hypothesis protocol and hypothesis reports related to OOS/OOT and Incidents. Co-ordination with R&D, Production, Central Cell, CQA and other responsible for investigations. To prepare and review Quality documents such as (but not limited to) protocols, reports, SOPs STPs Specification, Investigation. Preferred candidate profile Perks and benefits

JOB DESCRIPTION Review and approval of change controls Review and approval of investigation reports (OOS, OOT, market complaints, returned goods, recalls) Handling of regulatory and customer audits Conducting self-inspection audits across various departments Managing customer queries Preparation and review of SMF, VMP, and SOPs Overseeing the vendor qualification program Overseeing the training program Area of expertise - Analytical data review Other skills - Should have knowledge on cGMP systems and Regulatory guidelines.

QMS strengthen, responsible for internal & external audits. Certified Internal auditor IATF 16949:2016, ISO 14001:2015 & ISO 45001:2018. Preparation for MACE audit as per Mace audit check sheet.

General Manager - Mechanical/E&I/Electrical/Production Cement Plant Qualification : BE/B.Tech/Diploma Mechanical/Electrical/Production/Instrumentation E&I Principal Duties and Responsibilities: - Conceptualize and implement capital expenditure proposals within the cost and time. - Feasibility study of projects - Planning & execution of projects - Provide leadership to the project team in coordinating and administering the project. - Planning, engineering, procurement throughout construction and start-up activities. - Establish and maintain liaison with vendors, customers, contractors/subcontractors throughout the entire cycle of the project to resolve problems and co-ordinate all service functions. - Planning and establishing schedules, forecasts, budgets and monitors progress to assure schedules are met and work performed effectively within target. - Monitor and control all contractual commitments to ensure work is being performed in accordance with the specifications and terms of contract. - Monitor the cash flow to minimize the use of the company's capital resources on the project. - Build up and motivate the team to perform at a high level of integrity and professionalism. - Effective management of human resources of the organization according to authorized personnel policies and laid down procedures. - Identify, hire and manage the staff, colleagues. - Oversee the sourcing and analysis of various investments made and benefits. - Regular interaction and coordination with allied departments and top management. - Selection of external parties to conduct specific assessment and / or detailed engineering / cash analysis and development. - Overseeing the environment & safety programs and field work including company and sub-contractor employees. - Coordinating with other departments Preparation & checking of machine drawing & fabrication drawing (GA Drawing & other Detail drawing) with Bill of Material. Scheduling, Monitoring & Co-ordination of Project on daily/monthly basis. Calculation of Material Take-off, quantity calculation and Planning for the Procurement of the material & Consumables as per working schedule. Preparation of Completion schedule and Planning for sequence of fabrication as per required delivery schedule and Manpower. 3D Modeling, Assembly, Detailing & Stress Analysis using CAD Tool. Co-ordination with Vendors & satisfy their query. Meets with project managers to regularly review issues and monitor progress. Assists team members in the use of project support technology. Produce a progress report monthl i) Project Estimation, Project Management, Project planning, Project Engineering, Estimation, Metal Fabrication. ii) well proficient in GD & T & Engg. Symbol. iii) Well proficient in ANSYS, Auto Cad, MS Project. iv) knowledge for generating 3D Modeling, Assembly, Detailing & stress Analysis using CAD Tools. v) Well converse of IS, DIN standard. vi) Well proficient in engineering data maintaining on ERP software SAP & ms project. FOR GENERAL MANAGER ELECTRICAL Should have good exposure in Erection & commissioning as well as maintenance & trouble shooting of different Electrical Equipments. Good skills & experience in analysis, implementation of Schemes, Drawings, Cable schedule & termination details of electrical equipments. Spares Planning, Man power planning, Breakdown & Cost reduction by Productive maintenance/Preventive maintenance. Working in team for achieving the targeted goals of organization. Power monitoring of the drives and Energy conservation. Troubleshoots plant electrical problems to determine their cause and recommends options for eliminating such problems. Includes carrying out tests on equipment Condition Monitoring and Predictive maintenance of critical equipment and corrective actions to avoid breakdown. Material procurement through SAP and maintaining minimum spares for attending breakdown and reducing breakdown time. ISO documentation, Quality Circle formation for detecting problems and solving from shop floor employees. Conducting Safety audits within the department and ensuring the compliance from all the employees and updating the checklists and audit reports. Adopting power saving techniques in plant . FOR GENERAL MANAGER PRODUCTION Area of Exposure Looking after the Raw Mill & Coal Mill section with power monitoring and analysis for all section. Carrying out all measurement in Kiln section and Mill section. Doing stoppage analysis of Kiln , Mills and crusher section. Detecting and arresting false air across pre heater , kiln and mill section. Effective co-ordination with team members, Contractors & Service agencies for smooth operation of plant for achieving production targets. Reporting of CCR officers alongwith shift activities for mill operation round the clock Responsible for Raw material planning ,unloading ,stacking , Production & cost budgeting within the department Mill optimizing and process measurements Implementation of effective process monitoring & power consumption mastery in plant level Leading the energy management committee as power champion in plant Demonstrated excellence in executing cost saving initiatives like admixture & cementitious optimization, grinding aid optimization Expertise in shutdown management activities & CONFINED space champion Implementation of Mandatory group Safety standards & requirements of every aspects of job for a safe working condition as per Groups/BUs guide lines.. Implementation of IMS standards as departmental IMS coordinator. Monitoring & tracking of process parameters for ball mill, process bag filters & compressors. Calculation & management of grinding media, wear rate, equipment efficiency. Scheduling & execution of routine inspection & audit for all major equipment & process circuit Tracking & analysis of deviation from target parameters for all key performance indicators. Quality & operation optimization to maximize productivity without compromising quality . Taking several necessary process trial for improvement like PID tune-LUCIE, grinding aid trial, chemical gypsum optimization, separator efficiency etc. Energy management for plant & leading energy committee to achieve power consumption targets Supervision of all process & production jobs jobs at sites with following industrial safety norms. Development of plant improvement plan with EVA calculation Assisting in managing environmental activities by ensuring all compliances of consents & norms for grinding unit Conducting daily operation meeting with analysis of performance parameters Production department activities billing and SAP activity

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety, and quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation