Senior Associate

Malaysia, Malaysia

Job Description


Department Details

Role Summary

Packaging Jr/Snr/Associates
Packaging Associates are responsible for the daily operation of the automated machinery involved in packaging. They must have an acute understanding of the normal function of their machinery as well as a good understanding of basic troubleshooting.
Packaging Associates tend to work in shifts, these depend entirely on the set-up of their particular facility. While the specific tasks of each job may also differ based on the product being manufactured and the type of packaging involved, general tasks can include:

  • Startup and close down of their machine as necessary
  • Routine checks and preventative maintenance of equipment
  • Efficient completion of final assembly and then packaging processes (such as applying meeting the specification) if required
  • Product/Device labeling and Vision System inspection of final product
  • Completion of distribution documentation/Batch Record may also be a responsibility of packaging operators
  • May be required to move completed boxes of products - operation of a pallet jack would not be an uncommon preferred skill for these roles
  • Maintaining cleanliness of equipment and work area
  • Reporting issues when they arise - this should be done quickly to minimize any impact on the efficiency of production
  • Quality checks of their equipment, process or product in accordance with the site\'s quality requirements
  • Maintaining all relevant documentation for their equipment and/or process. This documentation is likely to include quality documentation, ensuring adherence to internal procedures as well as external regulations
Skills Required
  • Communication Skills - good written skills are required for reading and understanding the technical documentation for their equipment or process to ensure proper use. Must also be able to effectively explain issues when they arise, to senior colleagues or staff assigned to troubleshoot
  • Manual Dexterity - professionals in the area must have excellent hand-eye coordination and be able to perform potentially tricky actions quickly and correctly, for a prolonged period of time
  • Attention to Detail - must be able to maintain concentration and quickly notice deviations from normal function of their equipment
  • Basic mathematical skills - some basic mathematics may be involved, depending on the specifics of the facility and the product being packaged.
Key Responsibilities

Let\'s talk about Responsibilities
  • Design, develop, assist in procure & commission new packaging line in compliance to Pharmaceutical guideline, equipment, and production systems to facilitate the introduction of new products into packaging operation.
  • Conduct Process/Equipment FMEA\'s and appropriate Risk Assessments to ensure and demonstrate full compliance to product specification and requirements
  • Qualification of newly introduced line SAT, FAT,IT/IQ,OT/OQ, PQ and PPQ till commercial buy-off. Represent DP Packaging on new design project, actively provide constructive technical feedback and recommendations to ensure robust, end to end process for the intended product/market.
  • Engage external machine vendors/suppliers as appropriate. Understand potential risk, develop contingencies, track milestones and deliver project outcomes on time. Provide training on new equipment, processes & procedures as required to the operation team. Complete process Qualification/validation activities & protocols/documentation.
  • Identify & implement GMP practices, work along with the QE on Six-Sigma LEAN improvement actions. Assess and implement new improvement processes, equipment, and technologies for longer-term/sustainability. manufacturing requirements. Introduce new technology and lean processes (automation & digitization) to enhance operations efficiency.
Let\'s talk about Qualifications and Experience
  • Bachelor\'s Degree in engineering or related discipline.
  • Minimum 5 years of experience in manufacturing/operation engineering in Project/NPI capacity.
  • Demonstrated experience in high volume manufacturing process with extensive experience in developing talent and new equipment introduction.
  • Strong troubleshooting and technical skills. Ability to demonstrate in compliance Audit (ISO 13485, USFDA, EMA, NPRA)
  • Ability to multi-task and prioritize projects to meet changing priority/demands.
  • Demonstrated experience in leading junior team members and managing stakeholders.
Educational Qualifications

Required Education Qualification: BE/ B.Tech - Other
Required Experience: 1 - 20 years

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Job Detail

  • Job Id
    JD907171
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Malaysia, Malaysia
  • Education
    Not mentioned