Low-Bioburden Specialist

SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines addressing rare and life-threatening diseases.

We are committed to offering essential drugs meeting public health needs.

The Cleanroom Technician role performs routine production of low-bioburden serum in the Serum Production Facility to the required standards of our Quality Management System (QMS) and maintains the cleanroom facility to a standard approved by the Therapeutic Goods Administration (TGA).

• Under appropriate supervision, sustain the production of export grade TGA approved low bioburden serum in the cleanroom facility by performing routine production within the environmentally controlled, serum production facility via appropriate gowning, facility/equipment cleaning and behaving according to cleanroom procedures, current Good Manufacturing Practice (cGMP) and regulatory guidelines.
• Maintain complete and accurate documentation, both written and electronic. Paying particular attention to Good Documentation Practice (GDP), data integrity and right first-time completion of these documents.
• Perform timely reviews of accurate batch records and facility/cleaning logs.
• Facility environmental monitoring.
• Carry out specified cleaning procedures at required timeframes.
• Correct labelling, packaging, and handling of product for export.
• Assist Quality Control (QC), Quality Assurance (QA), Facilities, Logistics and Validation stakeholders with site-wide quality effort.