Production Associate – Documentation & Administration

The Production Associate – Documentation & Administration is responsible for preparing, administering and controlling production documentation to ensure manufacturing records are accurate, current, traceable and compliant with TGA, PIC/S GMP, GDP and company QMS requirements.

• Draft and maintain BMRs, BPRs, manufacturing instructions, worksheets, checklists and production forms.

• Ensure current approved documents are issued and obsolete versions controlled.

• Maintain production records, registers, batch status and ERP/MRP information.

• Prepare production reports covering output, yield, waste, downtime and schedule performance.

• Conduct initial administrative checks of completed batch records for completeness, signatures, calculations and reconciliations.

• Identify and escalate documentation errors, discrepancies and data-integrity concerns.

• Maintain production records in an audit-ready condition.

• Support deviations, investigations, CAPA and approved Change Controls.

• Retrieve production documentation for TGA and GMP audits.

• Identify opportunities to improve production documentation and administration.

• Accurate and timely preparation and issue of production documents.

• Completed BMRs/BPRs submitted within agreed timelines.

• High GMP/GDP compliance and minimal documentation errors.

• Accurate production reporting and record-keeping.

• Production documentation maintained audit-ready.

Responsible for the accuracy and administration of production documentation.

May draft, prepare and maintain production documents and recommend improvements.

May not independently approve specifications, GMP-critical documents, process changes, deviations, CAPAs or finished product release.

• Production administration or manufacturing documentation experience.

• Excellent attention to detail and organisational skills.

• Strong Microsoft Word and Excel capability.

• Experience in GMP-regulated manufacturing highly desirable.

• Knowledge of BMR/BPR preparation and TGA/PIC/S GMP desirable.

• Strong written communication and ability to manage deadlines.

GMP/PIC/S, TGA requirements, GDP/Data Integrity, QMS, Document Control, BMR/BPR, SOPs, Deviation/CAPA, Change Control and WHS.

The role is expected to start at 7:00am and finish at 3:00pm 

The role is site-based and expected to be completed at the office and in the GMP facility based in Ormeau.