qa batch release lead in Melbourne

posted
contact
melissa tuli, randstad
job type
contract

job details

posted
location
melbourne, victoria
specialism
science & technology
job type
contract
working hours
Full-Time
reference number
90M0429528_1604533805
contact
melissa tuli, randstad
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job description

About the company
Our client is a Global Pharmaceutical manufacturing company based in the Inner CBD suburbs of Melbourne. Due to recent growth, they are currently looking for an experienced Quality Batch Release Lead to be a part of their Global R&D quality team. This role has a Global focus for release of material for toxicology studies and clinical trials and associated R&D quality strategy. This role will be a 12 months contract with a possibility of further extension.

About you

  • Serves as the global R&D QA single point of contact for the sterile manufacture
  • Ensures material for GLP toxicology studies is produced and tested in accordance with the study protocol
  • Ensures that batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, etc. comply with site and global SOPs/Policies
  • Provide directions for Quality systems, especially with respect to Production, including contributing to and writing and implementing Deviations, Investigations, CAPA and Change Control reports
  • Oversee the manufacture, distribution and testing of products under development in R&D, either in-house or at third party suppliers
  • Act as a QA reviewer for Chemistry Manufacturing and Control (CMC)-related regulatory filings, briefing materials, investigator brochures, etc. for R&D projects
  • Supports internal audits and self inspections to ensure R&D quality systems are operated in accordance with established SOPs and GxPs
  • Interact with cross-functional R&D teams (e.g., Research, Technical Development, Clinical Development), Operations and other Global Quality functions (Global Quality Assurance, Quality Systems, etc.).
  • Other duties as required

What you'll need to succeed

  • Previous Pharmaceutical (GMP) and sterile experience is essential
  • Bachelor’s degree in Science or Pharmacy or equivalent
  • Raw Material, Drug Substance and Drug Product expertise in vaccines preferred (cell-based and/or Advanced Therapeutic Medicinal Products)
  • Experience working across different phases of R&D preferred (Product Development/GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
  • Experience applying GMP principles in different market areas (e.g., US and EU) preferred
  • Excellent written and verbal communication skills
  • Problem -solving and decision-making skills

If you are interested in this role, click on 'APPLY NOW' or alternatively contact Mel Tuli on 0434949909 or email your resume to melissa.tuli@randstad.com.au

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

qa lead, quality lead, quality assurance lead, QA manager

qualification

Bachelor's degree

educational requirements

Bachelor Degree