Job Details

Senior QA Associate (AP)

Life-Space Group Pty Ltd

Senior QA Associate (AP) 

At Life-Space Group, it’s our mission to make the latest scientific advances in the microbiome available to all and lead the way in Paediatric supplementation.

Our hero brand, Life-Space, is a leader in the global probiotic industry. Launched in 2012, Life-Space is passionate about unlocking the possibilities of the microbiome and empowering people of all ages to sustain and achieve long-term health.

We are on the hunt for a Senior QA Associate (Authorised Person) to join our Life-Space Group team. In this role you will be responsible for performing release processes for bulk and finished products, mentoring, and guiding your QA Associates and quality tasks arising from manufacturing projects. This role is an integral part of the LSG Quality team. 

Key components of the role include, but are not limited to:

  • Release for Supply of all products manufactured on site or at OEM as the Authorised Person (AP)
  • Management of the Release for Distribution process
  • Ensure a review of the Marketing Authorisation, product PQR and stability data is conducted as part of the Release for Supply process.
  • Approval and rejection of all finished products for the site.
  • Demonstrate strong technical knowledge and understanding of each product.
  • Co-ordinating with external contract manufacturers for any quality non-compliance issues for delivered bulk and finished product.
  • Maintaining an electronic filing system of all Quality documents pertaining to area of responsibility.
  • Development of company SOP’s and other controlled procedures and documents as appropriate.
  • Management of stability programmes for all products.
  • Prepare PQR and assist in management of PQR programme.
  • Participating in internal and external audits
  • Participate in cross-team activities e.g investigations, risk assessments as appropriate.
  • Assist with deviations, Out of Specification investigations, Change Requests, root cause analysis and risk assessments related to finished products.

What you will have:

  • Tertiary qualification in pharmaceutical science or microbiology is preferred.
  • Minimum 7 years’ experience in pharmaceutical or complementary medicines industries, mainly in the areas of manufacturing, quality assurance and/or quality control.
  • Minimum 3 years’ experience in Finished Product Batch Release
  • Proven supervisory or management experience of a small team.
  • Excellent knowledge of cGMP and PIC/S guide
  • Excellent interpersonal and leadership skills
  • High attention to detail, excellent time management & organisational skills
  • Strong leadership & people development abilities
  • Excellent verbal & written communication & proficient PC skills
  • Cross functional problem solving & decision making.

In return, you will receive:

  • Competitive salary with 
  • Range of competitive employee benefits including a paid parental leave program
  • Family and Friends quarterly product allowance across the Life Space product range
  • Highly supportive culture that fosters continuous development

If this is you please click the "Apply now" button below and include a covering letter with your application. 

Please understand that due to the volume of applications we receive only short-listed candidates will be contacted.

For further information on Life-Space Group visit www.lifespaceprobiotics.com   

Job Overview

  • Published On
    : 2023-11-12
  • Job Type
    : Full time
  • Experience
    : 不限
  • Qualifications
    : 不限
  • Job Location
    : Clayton, Melbourne VIC
  • Gender
    : 不限
  • Salary Type
    : 不限
  • Salary
    : 面议

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