Cleanroom Technician at SERB

, , Australia -

Full Time

Start Date

Immediate

Expiry Date

03 Jun, 26

Salary

0.0

Posted On

05 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Gowning, Facility Cleaning, cGMP, Regulatory Guidelines, EHS Guidelines, Documentation, GDP, Data Integrity, Batch Records, Environmental Monitoring, Labelling, Packaging, Handling, Problem Solving, Teamwork, Communication

Industry

Pharmaceutical Manufacturing

Description

Current Opportunity SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases. Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs. Our commitment is to continue to offer essential drugs meeting Public health needs. Are you seeking a job that makes a difference? Join a team that teaches you on the job skills which directly contribute to saving lives across the globe! BTG Pty Ltd are seeking a Cleanroom Technician with a can-do attitude to join the team at our Rosedale location 4 days per week (Tuesday, Wednesday, Thursday, Friday). The role of the Cleanroom Technician is to perform routine production of low-bioburden serum in the Serum Production Facility to the required standards of BTG’s Quality Management System (QMS) and assist in maintaining the cleanroom facility to a standard approved by the Therapeutic Goods Administration (TGA). All training will be provided for the right candidate. Principal Responsibilities 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. Adhering to clearly defined quality and Environmental Health & Safety (EHS) guidelines to maintain a clean and safe workplace, aiming to prevent accidents and incidents. Maintaining 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. Performing timely reviews of accurate batch records and facility/cleaning logs. Facility environmental monitoring. Carrying out the specified cleaning procedures at the required timeframes. Correct labelling, packaging, and handling of product for export. Assisting Quality Control (QC), Quality Assurance (QA), Facilities, Logistics and Validation stakeholders with the site-wide quality effort. What we offer 5 weeks annual leave Up to 3 days of additional leave over the Christmas period Access to our EAP Program Superannuation salary sacrifice Skills and Attributes Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment. Organisational skills should be strong, with an ability to plan ahead. Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues. Must be able to work as part of a team and demonstrate initiative when required, with a flexible and willing attitude at all times. Strong written and oral communication skills. Highly self-motivated and directed. Knowledge of Microsoft Office is strongly desired. SERB Pharmaceuticals represents the merger of SERB, BTG Specialty Pharmaceuticals and Veriton Pharma to form a new, global specialty pharmaceutical company focused on critical care and rare diseases. Serb Specialty Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.

Responsibilities

The technician will sustain the production of export-grade, TGA-approved low bioburden serum within the cleanroom facility by performing routine production tasks and adhering to cGMP and regulatory guidelines. Key duties include facility/equipment cleaning, maintaining accurate documentation following GDP, performing environmental monitoring, and assisting various site stakeholders with quality efforts.