Senior Quality Assurance Associate
2 weeks ago
$50.61 – $56.61 per hour + superannuation
Proclinical is seeking a Senior Associate, Quality Assurance Compliance to join our client, a global Biopharmaceutical leader renowned for its innovation and commitment to delivering medicines to treat health conditions and improve quality of life. At their Broadmeadows site, they manufacture life saving blood plasma derived medicines.
Role Overview
Reporting to the Senior Manager Quality Assurance Compliance, the Senior Associate, Quality Assurance Compliance is responsible for the management of third party and regulatory inspections, internal audits and self-inspection programs in addition to intracompany and blood service quality agreements, supporting quality assurance activities, conducting gap assessments, preparing for inspections, and contributing to compliance initiatives.
Team Size: 10 people
Duration: 6-month contract
Start Date: ASAP
Hours: Standard Mon to Fri hours. May be overtime during inspections, willing to pay overtime or do time off in lieu.
Capacity: Mostly onsite, with 1 day from home
Location: Broadmeadows, 3047
WHV: Yes - must be available for the full 6-month duration
Role Responsibilities
Gap assessments (Inspections require gap assessments)
Write Data reports data/reports and analyses to support quality reviews including: Annual Product Quality Reviews, plasma master file updates, site KPIs and the global and local quality metric reviews.
When there is an inspection on site – person will be involved in the inspection (eg collation of requests for front office to present to auditors)
The role is quite a varied role
Deviation clusters, blood bank and quality agreements
Preparation for inspections
Rectifying some gaps for example - for providing Alburex to China
Skills and Experience
3+ years of experience in a quality compliance role within a regulated industry (ideally pharma)
Bachelor Degree in Science, Engineering or Pharmaceutical Science
Background in microbiology and/ or biochemistry (highly regarded)
Experience with electronic document management systems (eDMS) Information Databases and reporting such as Veeva and Trackwise systems
Demonstrated flexibility to manage changing priorities
Demonstrated ability for conceptual and analytical thinking with good judgement to reconcile ambiguities
How to Apply
If this opportunity aligns with your experience and career goals, please click 'Apply Now' to submit your application.
For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong via email at [emailprotected] or call 02 9054 7411 .
About Proclinical
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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