Description
DUTIES INVOLVE (but are not limited to): INITIAL DUTIES:
- Assisting with fine-tuning the design of the manufacturing facility for TGA, cGMP compliant API and FDF production (multiple dosage forms)
- Assessing process and personnel flows within the manufacturing facility
- Assisting with installation and validation of equipment and processes
- Designing manufacturing procedures and documentation
- Sourcing manufacturing equipment
- Instigating appropriate maintenance schedules
- Creating manufacturing documentation – SOPs, WIs, batch documentation, validation
- protocols
- Liaising with the Quality Manager to perform equipment, process, cleaning validation.
- Ensuring that processes are OHS compliant
ONGOING DUTIES will include:
- Daily operational activities of the manufacturing facility ensuring that all manufacturing activities are compliant (TGA) and safe and that production targets are met.
- Operating manufacturing equipment
- Production scheduling
- Recruit, manage and train production staff (e.g. in safety, cGMP, technical skills, process
operations)
- Completing/reviewing batch documents
- Troubleshooting and preventative maintenance of equipment
- Participating in internal and external audits
THE SUCCESSFUL CANDIDATE WILL POSSESS:
• Bachelor of Science, Engineering or related
• Significant experience in a similar role, within a pharmaceutical manufacturing environment• Proficient skills with composing, updating, and maintaining technical documentation
• Strong trouble-shooting abilities (equipment) and high mechanical aptitude
• Project management experience
• Excellent communication skills - Both written and verbal
• Attention to detail
MINIMUM REQUIREMENTS:
• Australian resident
• Australian Federal Police Check
• Drivers Licence
DUTIES INVOLVE (but are not limited to): INITIAL DUTIES:
- Assisting with fine-tuning the design of the manufacturing facility for TGA, cGMP compliant API and FDF production (multiple dosage forms)
- Assessing process and personnel flows within the manufacturing facility
- Assisting with installation and validation of equipment and processes
- Designing manufacturing procedures and documentation
- Sourcing manufacturing equipment
- Instigating appropriate maintenance schedules
- Creating manufacturing documentation – SOPs, WIs, batch documentation, validation
- protocols
- Liaising with the Quality Manager to perform equipment, process, cleaning validation.
- Ensuring that processes are OHS compliant
ONGOING DUTIES will include:
- Daily operational activities of the manufacturing facility ensuring that all manufacturing activities are compliant (TGA) and safe and that production targets are met.
- Operating manufacturing equipment
- Production scheduling
- Recruit, manage and train production staff (e.g. in safety, cGMP, technical skills, process
operations)
- Completing/reviewing batch documents
- Troubleshooting and preventative maintenance of equipment
- Participating in internal and external audits
THE SUCCESSFUL CANDIDATE WILL POSSESS:
• Bachelor of Science, Engineering or related
• Significant experience in a similar role, within a pharmaceutical manufacturing environment• Proficient skills with composing, updating, and maintaining technical documentation
• Strong trouble-shooting abilities (equipment) and high mechanical aptitude
• Project management experience
• Excellent communication skills - Both written and verbal
• Attention to detail
MINIMUM REQUIREMENTS:
• Australian resident
• Australian Federal Police Check
• Drivers Licence