Quality and Regulatory Officer – Biotech

Quality and Regulatory Officer – Biotech (The position has been filled)

• Rare Career Opportunity for an Early Career Scientist
• Assist in the management and maintenance of stringent quality systems
• Excellent Facilities in a Team Based Work Environment

 

CLIENT

Our client is a well-known, successful biotech company based in Melbourne. Due to the success of their innovative products in Australia and abroad, they continue to grow and excel.

Boasting modern facilities and a wide array of sophisticated manufacturing and analytical equipment, they offer a professional and supportive work environment where people respect each other and work together to achieve common goals. Everyone contributes to and shares in the success of the organisation. With a focus on working safely whilst delivering the best quality products as efficiently as possible, they seek a communicative and highly organised individual to join their Quality & Regulatory team.

 

ROLE

This rare and exciting entry level position, is ideal for a Chemist who wants to pursue a career in Quality & Regulatory Affairs within the biotechnology field. It is a varied role and presents an excellent opportunity for someone who wishes to learn and develop their skills in quality systems in a highly regulated environment. You will be trained to become responsible for managing the change control process; record management; and providing assistance for Quality Management Review meetings. Whilst the focus is on Quality, a Regulatory component to the role will have you providing assistance to ensure development projects have all associated records and documents to the requisite standards.

Training will be provided to ensure you can meet the following key requirements:

• Quality Systems documentation preparation, improvement and maintenance
• Management of change control processes
• Administration of the company training programmes
• Assistance in preparation for Quality Management Review Meetings
• Assistance in the Internal audit, CAPA and other quality programmes
• Assistance in the investigation of Out of Specification / Out of trend / Out of Limit investigations are conducted in accordance with established procedures
• Records management, including: Common Technical Document (CTD); Design History Files (DHF); Device Master Record (DMR); and Device History Record (DHR)
• Awareness of and compliance with Occupational Health and Safety legislation
• Assisting with the identification, analysis and management of risks associated with areas of responsibility and expertise

 

REQUIREMENTS

A true team player, the ideal candidate will ideally meet the following criteria:

• A tertiary qualification in Chemistry or similar scientific discipline
• Excellent attention to detail and organisational skills
• Excellent written and verbal communication skills
• A diligent, hardworking individual with a strong work ethic who can champion tasks to completion
• Flexibility to deal with a change in priorities at short notice
• Good interpersonal skills with the ability to constructively interact and collaborate with others in the team
• Excellent time management skills, including the ability to switch tasks rapidly
• Be optimistic and resilient, whilst willing to learn new skills and grow into the role
• Knowledge and/or experience working in a regulated setting and specific knowledge of GLP, GMP, GCP and ISO 13485 would be highly regarded

 

APPLICATIONS

Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

If you would like to know more about this unique opportunity please call our team at CS Executive Group on 03 9516 0100.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we cannot contact all candidates.  Please note, however, if you are not successful on this occasion, your resume will remain on our database and you may be contacted for other similar roles.