Validation Specialist

Validation Specialist

ANZCO code: 233914

About NovaCina: 

Novacina is a Perth based pharmaceutical manufacturing facility suppling sterile and injectable medicines to Australia and countries around the world.  Our vision is to be the foremost leader in the field of sterile injectable pharmaceuticals by offering highly specialised and differentiated products that meet the diverse needs of healthcare providers and patients worldwide.

Position Overview: 

We are looking for a meticulous Validation Specialist to join our Quality Operations (QO) team. Reporting directly to the QO Validation Manager, the Validation specialist will play a crucial role in ensuring that all equipment, facilities, utilities, and processes meet both on-site and regulatory standard requirements. The successful candidate will be responsible for the initial validation as well as the ongoing assessment and qualification of various systems critical to our operations.

Key Responsibilities:

• Execute initial validation protocols for equipment, facilities, utilities, and processes according to established procedures and regulatory guidelines.
• Perform routine monitoring, testing, and analysis to ensure ongoing compliance with quality standards.
• Conduct risk assessments and participate in the development of validation strategies and protocols.
• Collaborate with cross-functional teams including Manufacturing, Quality Control, and Engineering to coordinate validation activities and address any issues or discrepancies.
• Generate comprehensive validation documentation including protocols, reports, and standard operating procedures (SOPs).
• Assist in the investigation and resolution of validation-related deviations, discrepancies, and non-conformances.

Qualifications:

• Bachelor's degree in a scientific or engineering discipline preferred.
• Minimum of 2 years of experience in validation or quality assurance within the pharmaceutical or biotechnology industry.
• Strong understanding of cGMP regulations and guidelines (e.g., FDA, EMA).
• Experience with validation protocols, risk assessments, and documentation practices.
• Excellent analytical skills with a keen attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

Why Join NovaCina: At NovaCina, we offer a collaborative and innovative work environment where employees are encouraged to grow both personally and professionally. As a member of our team, you will have the opportunity to make a meaningful impact on the lives of patients worldwide while advancing your career in the pharmaceutical industry. We provide competitive compensation and benefits packages, along with ongoing training and development opportunities.

If you are passionate about quality and committed to excellence, we invite you to join us in our mission to redefine healthcare through innovation and dedication to patient care.

This role will work out of our facility at Brodie-Hall Drive Bentley WA 6102

Posted date 14 March 2024, closing date 14 April 2024

How to Apply: 

To apply Validation Specialist position, please submit your resume and cover letter outlining your qualifications and relevant experience. We look forward to welcoming you to our team and working together to drive innovation and success in the pharmaceutical industry.

NovaCina is an equal opportunity employer and is committed to diversity in the workplace. We encourage applications from all qualified individuals, including those with diverse backgrounds and those with disabilities.