Excellent Opp. for R&D Quality Specialist to join global pharma org. for major project work & write, review & approve GMP documents.

About the Organisation Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for their operational excellence, passion for innovation and are a global leader in the healthcare industry. Due to global expansion and growth, an opportunity has now arisen for a R&D Quality Specialist to be responsible for all quality documentation & work with EQMS systems & ensure manufacturing areas are compliant as per regulations.

About the Opportunity Reporting directly into the R&D Senior Manager, key responsibilities include : Review & approve of key GMP documentation, SOP’s, reports, qualification, R&D deviations & change controls. Ensure manufacturing release teams are up to speed with compliance aspects & work with EQMS systems. Support the execution of the qualification & validation program for the new manufacturing facility.

Provide compliance specialist advice on qualification & validation issues for the new manufacturing facility. Effectively liaise with R&D departments regarding quality related issues associated deviations, change controls & out of specifications. About You - Skills & Experience Tertiary qualifications in Science or related discipline.

Minimum of 5 years' experience in GMP, QA, Regulatory Affairs. Sound experience of GMP requirements in the pharmaceutical industry, medical device, biotech with Quality, R&D including qualification & validation. Sound interpersonal, negotiation & influencing skills.

Strong analytical & problem solving skills. Well-developed organizational & time management skills. Sound relationship building skills with R&D, Validation, Engineering & Manufacturing & the ability to influence key stakeholders.

Culture & Benefits This is an excellent opportunity for a R&D Quality Specialist to join global pharmaceutical organisation & be responsible for all quality documentation & manage quality compliance aspect for a new major project. This is a long term contract opportunity requiring immediate start. How to Apply To apply for this opportunity, please click on the APPLY NOW button and forward your CV in MS Word.

For a confidential discussion, please contact Sue Campbell on 0417 994 917 or Mal Menon on 0420 665 171. NB - Only shortlisted candidates will be contacted..