Plant Quality Leader

7 days ago

bawal, India BD Full time

Job Description Summary- To develop, implement, drive, sustain and continuously improve an effective Quality Management System for the Plant in line with BD WW norms, ISO, CE. Ensuring compliance to all quality assurance activities, regulatory and corporate requirements are complied with for all products manufactured in the Plant and release products which are compliant to above standards.- To build, implement, drive, sustain and continuously improve process validation and control capabilities for existing as well as new products to achieve product quality in compliance to BD's Standards and Regulatoryrequirements in line with BD WW norms, ISO, CE.- To ensure that plant meets all needed regulatory compliance and continue to upgrade compliance standardJob DescriptionResponsibilities include but are not limited to:Quality Assurance to enhance quality standards of plant1. Ensure Development & maintenance of quality system for all aspects of plant operations including 1SO 9001, ISO 13485.2. Assists with supplier and internal audits, as a means of evaluating the effectiveness of the established Quality Systems and Good Manufacturing Practices3. Corporate Quality AuditsQuality Control1. Ensure on-time and effective testing of incoming material, in-process material and finished product2. Ensure microbiology testing and quality testing for raw material, packaged material, assembledcomponents, finished goods etc. and stability studies3. Ensuring on time release of all products from plant4. Ensure design & validate test methods for quality and microbiology testing5. Ensuring lab practices are improved continuously in line with Good Laboratory Practices6. Ensuring that Change Control process is followed for all material, process & product related changes.Regulatory Compliance1. Ensure Corporate and regulatory compliance of the product2. Ensure availability of new or renewed manufacturing license for products3. Handling Regulatory inspection & certification from India as well as other countries/agencies4. Ensure proper maintenance of batch records for products.Process Validation, Change Control, Sterilization Validation and Clean Room Testing1. Supporting introduction of new product & processes by effective process validation and upgrading Bawal's Quality System to support new products.2. Ensure Change Control process from initiation to end, till ECO release.3. Ensure effective validation of manufacturing & test processes4. Ensure implementation MSA (Measurement System Analysis) for CTQs.5. Well conversant with Root Cause Analysis techniques. Facilitate route cause analysis for major processand product failures, implement effective and sustainable corrective and preventive actions.6. Ensure Establishment and maintenance of product quality plan, control plan, process FMEA, validation or re-validation plan, product quality performance review and trending data for the processes and for continuous improvement efforts.7. Ensure Validation / revalidation of sterilization8. Ensure Validation / calibration of quality assurance equipment9. Ensure Environment monitoring for clean rooms.Customer Complaint1. Customer complaint Analysis, trending and adequate & timely redressalPeople development1. Provide leadership and guidance to quality team2. Ensure timely Performance Evaluation3. Driving Team building and associate engagement initiatives4. Develop validation capability for plant and leading VRB initiativeRequired SkillsOptional SkillsPrimary Work LocationIND Rewari - BawalAdditional LocationsWork Shift

  • Plant Quality Leader

    6 days ago

    IND Rewari - Bawal, India BD Full time US$ 60,000 - US$ 1,20,000 per year

    Job Description Summary- To develop, implement, drive, sustain and continuously improve an effective Quality Management System for the Plant in line with BD WW norms, ISO, CE. Ensuring compliance to all quality assurance activities, regulatory and corporate requirements are complied with for all products manufactured in the Plant and release products which...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary:We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope, timeline,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary:We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope, timeline,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary:We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope, timeline,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary: We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary:We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope, timeline,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary:We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope, timeline,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary: We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary: We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope,...

  • Deputy General Manager

    2 weeks ago

    Bawal, India Lumax World Full time

    Job Summary: We are seeking an experienced Project Manager with strong project management expertise and working knowledge of electronics design, development, or manufacturing processes. The ideal candidate will lead cross-functional teams, manage end-to-end project delivery, and ensure successful execution of electronics-based projects within scope,...