Validation Officer

Description:

As the Validation officer you will help to deliver the validation and “go-live” of our client's new facilityin Brisbane.
Who will you be working with?

Our client is an industry leader in the health and wellness space, dedicated to improving consumer health worldwide. Our client leverages their expertise and innovative approach to manufacture a diverse range of functional healthcare products.
This role will collaborate closely with our client teams based in Australia and China. The successful candidate will be responsible for developing the validation documents, performing and documenting validation testing for their new manufacturing and packaging site as well as generating the SOP documentation and training materials, as required. This role will work closely with a cross-functional team to ensure that project meets its objectives and “go-live” date.
What are the benefits?

• Opportunity to join an industry leader at the forefront of innovation
• Join a skilled and professional team in a leadership capacity
• Ongoing training and development opportunity
What will you be doing?

• Develop / execute the validation protocols, and complete reports for the new site, utilities and equipment as required in their new site.
• Ensure the facility, utilities and equipment validation documentation is prepared in line with TGA GMP standards for solid dose complementary medicines
• Generate all required SOP documentation and related support systems.
• Generate training documentation and help lead the training process for the new manufacturing staff.
• Document maintenance schedules and spare parts requirements, as applicable.
• Communicate efficiently and effectively with key stakeholders to ensure they are updated on all key milestone delivery.

What do you need?

• Demonstrated experience in all aspects of validation activities within pharmaceutical environment, as they relate to solid dose manufacturing and packaging of Complementary Medicines.
• Demonstrated experience in generating SOP documentation and training materials and their supporting systems.
• Strong written and verbal communication skills, with a demonstrated ability to engage with local and global cross functional teams.
• Working knowledge of TGA GMP requirements for AUST L and OTC medicines, and their manufacture and packaging.
• Technical knowledge of basic engineering requirements.
• High attention to detail and ability to meet tight deadlines.
• Strong QA background with working knowledge of QA processes is highly recommended, including but not limited to Non-Conformances, Deviations, CAPAs, Customer Complaints, Change Controls.
• Experience with ERP systems, and computerised systems that may interface with equipment or manufacturing systems.
• A positive / “Can Do” attitude and mindset to be part of a dynamic and diverse work environment.

Apply Now , OR with any specific questions, please contact Christelle Capini at ccapini@fuserecruitment.com.
At Fuse, we specialise in recruitment for the scientific and manufacturing industry, and actively source a variety of roles for a broad range of organisations. If you are looking for a new opportunity, we’d love to hear from you!
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