Technology & Product Development Manager

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November 04

Job Description

Major Accountabilities :
Responsible for New Product Introduction, Technology Transfer and strategic/operational projects at site level, including scale-up. Lead packaging projects based on regulatory and business needs, upgrade packaging machine with robust system based solutions. Introducing New Metrology equipment’s and methods to improve the efficiency of the manufacturing process. Lead digitalization projects to simplify manufacturing process and utilization of big data. Drive business continuity projects, second source vendor qualification for critical materials.

Essential Functions :

  • Lead SAP (System Analysis Program) implementation project to change the business operation landscape, able to lead the Cutover role for the project, coordinating with various functions both internal and external to develop overall cutover strategy, detailed cutover plan, business contingency plan, rollback plan, simulation plan, Volume testing, DitL (Day in the Life) testing, hyper care plan etc.
  • Lead New product introduction at site and liaises efficiently with site functional department.
  • Lead Technical transfer project at site and liaises efficiently with transfer site.
  • Conduct FEED ( Front End Engineering Design) study, Feasibility study and site readiness activities.
  • Hands on experience with advanced molding machine to determine optimal parameter settings.
  • Able to understand the automation system to optimize product yield and cycle time.
  • Expertise in data analysis tools to determine the mold prediction models.
  • Establish continues monitoring system to monitor the product performance.
  • Able to create program and tune the metrology equipment to perform in-process measurements for existing and new products.
  • Hypercare for the completed projects for a minimum of 6 months to ensure the implementation are robust.
  • Provide technical expertise together with site experts for continuous improvement and issue resolution.
  • Develop inspection sheets with prediction formulas, specification conditions and next step guidance based on the inspection results.
  • Lead and Manage strategic/operational projects at site based on organization need.
  • Strategic focus on metrology and packaging Projects based on business needs.
  • Identify state of art metrology system to perform in-process inspection.
  • Lead the primary and secondary packaging projects at site based on the regulatory and business needs, adding new requirements, artwork changes.
  • Lead packaging machine qualification projects (new and upgrades) with robust system based solutions. Such as centralized Database to hold the material details and auto calculation of dates.
  • Expertise in Cutover process to implement new changes without interruption to business (new system, new materials etc.)
  • Manage/maintain/ensure project file/documentation (e.g.: project charter, planning/timeline, execution plan/actual, lesson learnt etc.)
  • Define and monitor project scope, timing and progress.
  • Initiate change control in system and ensures approval and closure.
  • Able to write Manufacturing Process Transfer Documents (protocol, report).
  • Able to write Validation Documents  as per below :
  • - URS (Use Requirement Specification)
  • - FDS (Functional Design Specification)
  • - FRA (Functional Risk Assessment)
  • - HLRA (High Level Risk Assessment)
  • - QNA (Qualification Need Assessment)
  • - BIA (Business Impact assessment)
  • - MVP / VP (Master Validation plan/ Validation Plan)
  • - TS (Test Script)
  • -  IQ (Installation Qualification)
  • - OQ (Operational Qualification)
  • - PQ (Performance Qualification)
  • - OQP (Operational and performance Qualification)
  • - IOQP (Installation, Operational & Performance Qualification)
  • - Any others relevant reports
  • Apply Regulatory knowledge to understand the requirements and prepare related documents for the projects handled.
  • Ensure that all activities are performed to current standards (current Good Manufacturing Practices , Health Safety Environment , Regulatory etc.).
  • Perform investigation for the deviations found during the execution identify the root cause and provide corrective actions.
  • Expertise in designing, developing  and qualifying new systems to automate manual process via new applications ensuring stable, data integrity proof and easy to use system to achieve digitization goal.
  • Design the process flow; identify critical data collection, identifying interacting sub systems, form designing to meet the quality and manufacturing needs. Highlight the out of specifications and missing information in real time. Communication with SAP system if needed.
  • Internal Auditor – Responsible in participating and conducting self-assessment as per audit schedule.
  • Accountable to answer the auditor during external audit.
  • Initiate monitoring and CPV (Continued Process Verification) phase.
  • Support process and quality improvements projects.
  • Support local business and administrative processes as an HSE committee member. .
  • Review the measure taken to ensure the safety and health of co-workers at the workplace. Highlight to safety and health committee of any safety matters observed or raised by employees.
  • To assist in the development of safety and health programs and safe system of work.  Review the effectiveness of safety and health policies and programs.  Inspection of workplace, report unsafe conditions and unsafe acts. Participate in incident investigations and recommend corrective actions. Carry out studies on the trends of accidents, near miss accident, dangerous occurrence occupational, poisoning or occupational diseases, which occurs at the workplaces.

Job Requirements

  • Bachelor Degree in Engineering / Science
  • Minimum > 8 years working experience in project management, new product introduction in a pharmaceutical/medical device/regulated manufacturing plant
  • Minimum >5 years leadership experience
  • Thorough understanding of manufacturing processes and related process / equipment
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
  • Expert in reviewing and writing technical reports
  • Fundamental understanding of standard medical device/pharmaceutical regulatory requirements
Skill & Language
echnology & Product Development
4 - 6 years
1 candidate
December 06
Full Time
Kepong, Kuala Lumpur
Alcon4 jobs · Kepong, Kuala Lumpur
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