Quality Operations Specialist

Novacina is a Perth based pharmaceutical manufacturing facility suppling sterile and injectable medicines to Australia and countries around the world.  Our vision is to be the foremost leader in the field of sterile injectable pharmaceuticals by offering highly specialised and differentiated products that meet the diverse needs of healthcare providers and patients worldwide.

Quality Assurance Aseptic Support

• 12-month maximum term contract
• Exciting Opportunity.
• Competitive Remuneration.
• Only applicants with Australian working rights will be considered.

Reporting to the Aseptic and Environmental Control Manager and associated team members you will be involved with performing appropriate levels of cGMP compliance to the site aseptic practices and media fill program. 

This includes performing and/or assisting in:

1. Design, execution and maintenance of the following aseptic processes:

• Site media fill program.
• Site Container Closure Integrity (CCI) program.
• Gowning qualification program.
• Site Environmental Monitoring (EM) program.
• Site cleaning and disinfection program. 

Including preparation of protocols, aseptic process auditing and reporting. 

1. Supports the Manufacturing Manager, manufacturing team and manufacturing shifts to ensure maintenance of cGMP throughout normal business and through change. Including assisting in identifying and solving quality assurance problems in the plant and after-hours attendance at site to support aseptic oversight activities. 
2. Maintenance of media fill batch documents and GMP documentation associated with the media fill program and other relevant aseptic systems as directed by the Manufacturing Manager.
3. Media fill auditing of aseptic practices. 
4. Writing Manufacturing Investigation Reports (MIR) and implementing required Corrective and Preventative Actions (CAPA). 
5. Lead training for aseptic manufacturing related changes. 

This position liaises with personnel from Operations and Quality areas to ensure the above objectives are completed in a timely and compliant manner.

Key Roles & Responsibilities 

• Review and approval of GMP documentation and aseptic manufacturing practices
• Organisation support - including after-hours attendance at site 
• Aseptic process auditing
• Participate in internal and Board of Health (BoH) audits
• Adhering to and promoting critical aspects for site involving:
• Cultural Attributes
• Statutory Obligations
• Environmental Health and Safety
• Team Coordination

Essential

Qualifications

• Tertiary qualification in Microbiology or, a science-based discipline relevant to pharmaceutical manufacturing.
• Minimum 1 year manufacturing, or technical experience in the pharmaceutical industry (preferably involving aseptic manufacture and BFS technology).
• Experience in problem solving, preferably with a range of staff functions and responsibility levels.
• A basic understanding of Windows computer applications.

Competencies

• Exceptional functional & technical skills
• Listening & effective decision making
• Problem Solving & innovation 
• Composure
• Ability to learn on the fly
• Excellent verbal & written communication 
• Customer-focused drive

Desirable

• Minimum 3 years in a QC microbiology laboratory or aseptic processing cleanroom manufacturing department.
• Extensive knowledge of cGood Manufacturing Process.

To apply for this role, please send a cover letter addressing your suitability and a current CV. We thank all applicants for their submissions, however, only short-listed candidates will be contacted.