683 Capa Jobs - Page 28

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