• $105,000 - $120,000 + super
• Unique ground-floor career growth opportunity in new manufacturing facility
• Will be mentored by experienced Head of Quality

Exergy is a new business, funded by an established company, with a goal of becoming Australia's highest quality manufacturer of complementary and compounded medicines. We are nearing completion of the building phase of a brand-new facility at Smeaton Grange in Sydney.

Ever wish you could work in a facility that was purpose built with quality in mind from the very beginning? Want a chance at unique ground-floor opportunity to be a part of the first team to help validate brand new equipment and processes and watch the very first batch roll off the line? Looking for a high career-growth potential role in a company as it scales? This is that role.

The Validation Associate will report directly to the Head of Quality and will be responsible for validation and calibration activities for the site. In the first few months, the role will be solely focused on ensuring that all manufacturing and critical utility services are fully qualified to the Validation Master Schedule. Post-licensing phase as we move into manufacturing, the role will become a more traditional Validation role as described below. As manufacturing scales and we continue to add to our Quality team, there are career growth opportunities for a motivated high achiever.

This is an on-site role in Smeaton Grange. The salary will be negotiated inside the posted range based on your experience and seniority level. This role is best suited for a person in the mid to senior level of seniority who is looking to take the next step.

The Responsibilities

• Collaborate across the business to ensure validation activities align with business objectives;
• Perform validation and calibration activities for the site;
• Assist with maintaining a robust and compliant Validation Master Plan (VMP) in conjunction with the Validation Master Schedule (VMS) and ensure effective monitoring and adherence to the schedule;
• Ensure that all manufacturing equipment and critical utility systems used in the facility are fully qualified according to the Validation Master Schedule. Escalated any potential challenges or delays and reprioritised validation activities according to updated and approved schedules;
• Ensure Quality Risk Management is applied to all validation activities as appropriate;
• Prepare validation protocols and reports as per standard operating procedures for Qualification and Validation Documentation and other relevant associated validation procedures;
• Ensure the successful execution and completion of validation activities associated with new and existing equipment and processes;
• Collate, review, and data check results for validation reports;
• Ensure OOS, Deviations and Incidents, and non-conformance are appropriately investigated, and root cause analysis has been performed and appropriately documented;
• Escalate any significant quality issues and/or Out of Specification results that may impact product quality or regulatory compliance to the Head of Quality;
• Participate in the technology transfer process of NPD to commercialisation with cross-functional teams;
• Identify calibration requirements and acceptance criteria for measuring equipment. Ensure all calibration certificates comply with acceptance criteria or are appropriately investigated to ensure the facility remains in a compliant state;
• Prepare and review change controls as appropriate, providing justification if validation is determined to be “not required”;
• Participate in inspections that are performed by the TGA or other regulatory agencies in the area of responsibility;
• Maintain an electronic filing system of all Quality documents pertaining to the area of responsibility;
• Develop company SOPs and other controlled procedures and documents as appropriate;
• Demonstrate strong technical knowledge and understanding of each manufacturing and packaging process;
• Work with key stakeholders such as Production to ensure appropriate scheduling and completion of validation activities and documents.
  

The Technical Skills and Requirements

• Tertiary qualification in pharmaceutical sciences, science, or engineering is preferred;
• Minimum 2 years experience in pharmaceutical or complementary medicines industries, mainly in the areas of validation and quality assurance;
• Proficient computer skills in Word, Excel, and PowerPoint;
• Broad experience of validation activities and sound understanding of the principles of quality assurance and quality control functions;
• Excellent knowledge of cGMP and PIC/S guide, including proven experience in process and cleaning validation;
• Demonstrate strong technical knowledge and understanding of the inter-relationship of quality attributes and process parameters;
• Experience in the technology transfer process from NPD to commercialisation for complementary medicine will be highly regarded;
• Australian Permanent Resident or Citizen with the current right to work in Australia.
  

The Core Competency Requirements

• Excellent verbal and written communication skills;
• Excellent interpersonal, time management, and organisational skills who demonstrates ability to work independently;
• Attention to detail.
• Positive and proactive attitude.
• Cross-functional problem-solving and decision making.

*Please no recruiters and agencies. We are filling this role in-house.*