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July 22 2018

    Job details

Offer: QUALITY NPI ENGINEER:LOTUSWORKS

Job description:


   » Job ID.:15367067
   » Employer ID.:RI/LW QE CW 5876
   » Published:10-JUL-2018
   » income:Competitive
   » Job location:CARLOW
   » Employment Type:PERMANENT
advantages: LIFE ASSURANCE, PENSION / PRSA

 

About Us

A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class.

Location

A beautiful county is the south east region of Ireland, with the River Barrow flowing through the town; Carlow is home to its renowned Institute of Technology. It’s a great base if you want to be out of the hustle and bustle of the city but easy to reach Wexford, Kilkenny, Wicklow, Kildare, Laois & Dublin.

Your Job Purpose

Working with the LotusWorks team as a Quality/NPI Engineer, you will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities.

Responsibilities
   » Ensuring that the process for the introduction of biologics/vaccines follows cGMP and the connected regulatory requirements.
   » Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
   » Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers
   » Provide quality oversight and direction for the introduction of new products and drug substance onto site covering the end to end strategy.
   » Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
   » Participate as functional expert in the cross functional team that manages introduction of products.
   » Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
   » Facilitate batch release strategy between supply, manufacturing and packaging sites.
   » Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
   » Review other documentation connected with new product and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.) Requirements
   » Bachelor’s degree in engineering, Science or significant discipline
   » Minimum of 5 years’ practice working in a similar environment
   » expertise of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
   » expertise of cGMP and GDP preferred
   » Report, standards, policy writing expertise required
   » Equipment and process validation
   » Sterile filling processes and equipment
   » Proficiency in Microsoft Office and job-related computer applications required
   » Lean Six Sigma Methodology practice desired Benefits
   » Life Assurance
   » Pension Contribution
   » Training & Educational Assistance (Engineers Ireland CPD Members)
   » Healthcare Contribution
   » Annual GP Check-Up
   » Extra Annual Leave
   » Healthcare Screening Refer someone you know for this function and if we hire them you will receive a €250 voucher. (T’s & C’s apply) Click on the following link to Refer Your Friend today! http://www.lotusworks.com/en-ie/refer-a-friend

Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email jobs@lotusworks.com and we will be happy to help!

LotusWorks is proud to be listed in the Best workplaces 2017

Empowering talent we care about for over 29 years

LotusWorks is an Equal Opportunity Employer

This job originally appeared on RecruitIreland.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Carlow
Company Type Employer
Post Date: 07/10/2018 / Viewed 4 times
Contact Information
Company: LOTUSWORKS
Contact Email: jobs@lotusworks.com


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