05 Aug
|
Cai
|
City of Sydney
05 Aug
Cai
City of Sydney
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
Position Description
Assist with the setup and operationalization of the recent QC laboratory.
Lead or support the transfer, validation, and qualification of analytical methods for internal use.
Implement robust procedures for method documentation and compliance.
Perform quality testing of incoming raw materials to ensure conformance with specifications.
Conduct in-process quality assessments to support manufacturing and scale-up activities.
Execute and document final product testing to support batch release.
Investigate any out-of-specification results or quality deviations in coordination with QA.
Maintain high standards of GMP documentation and record-keeping.
Support the development of Standard Operating Procedures (SOPs), forms, and test records.
Assist with audits, internal inspections, and continuous improvement initiatives.
Requirements
Prior hands‑on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory workplace.
Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
Experience with method transfers and laboratory setup is highly desirable.
Understanding of GMP/GLP and regulatory expectations related to QC.
Excellent attention to detail, organization, and problem‑solving skills.
Ability to work autonomously and adapt to a quick‑moving, start‑up style environment.
J-18808-Ljbffr
📌 Qc Specialist City Of Sydney
🏢 Cai
📍 City of Sydney