Senior Validation Specialist

About Exergy

Exergy is a new business with a goal of becoming Australia's highest quality manufacturer of complementary and compounded medicines. With a brand-new facility at Smeaton Grange in Sydney, we're building a best-in-class team to achieve this aim.

About the role

We are looking for an experienced Senior Validation Specialist reporting to the Head of Quality.This is a unique opportunity to join a best-in-class team and help build a quality system from the ground up.

In this role, you will have the primary responsibility for validation activities and calibration requirements for the site.

Benefits

• You'll be an integral part of a new facility as we scale up
• Market leading compensation and growth opportunities
• Annual bonuses based on performance
• Positive work environment
• You’ll be working with an honest, hardworking, fun team

Accountabilities

• 100% adherence to Validation Master Schedule (VMS)
• KPI's for Quality Compliance and Operational excellence
• Build a best-in-class quality team that seamlessly integrates with the broader production team

Responsibilities

• Execute, and maintain a robust and compliant Validation Master Plans in conjunction with VMS and ensure effectively 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
• Work closely with Production and Management to ensure Quality responsibilities and resources are aligned with business objectives
• 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 equipment, process, and cleaning
• 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
• Prepare validation protocols and reports for NPD activities for pilot scale batches as required.
• 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”
• Liaising with both internal and external stakeholders

Technical skills & requirements

• Tertiary qualification in pharmaceutical sciences, science, or microbiology
• Formal qualification in internal auditing
• Minimum 5 years’ experience in pharmaceutical or complementary medicines industries, mainly in the areas, quality assurance and/or quality control
• Excellent knowledge of cGMP and current PIC/S guide, including proven experience in process and cleaning validation
• Proven experience in executing validation for process and cleaning
• Experience in a supervising a small team and strong leadership qualities
• Willingness to speak openly and constructively with colleagues, influence others in regard to quality
• Strong verbal and written communication skills
• Great attitude and punctuality
• Working numeracy/ literacy and computer skills
• Ability to motivate and lead teams
• The ability to work both in a team and independently with excellent time management and organisational skills
• Self-directed, taking initiative – performs tasks without being directed, see problems, and solves them without being asked
• A positive attitude, a willingness to help others learn and succeed

The job available to Australian Permanent Resident or Citizen with the current right to work in Australia.