Our client is a growing health and wellness company that is owned and operated within Australia. They have their own manufacturing base in Melbourne and a commitment to the health and good nutrition for the people of Australia and around the world. With a strong belief in doing good is good for business, hence a growing product range, they now seek an experienced Validation Specialist to join their team on a six month contract with a view to extend.
Due to growth, our client requires a motivated professional with at least five years’ industry experience in a similar role in pharmaceutical manufacturing. The ideal candidate will have a tertiary qualification in science, or a related discipline plus an in-depth knowledge of validation and understanding of relevant regulatory and compliance requirements applicable in a GMP facility.
If you are looking for an opportunity to be involved in the manufacture of innovative products and to be part of an experienced QA team, apply now!
Accountable for all validation activities in the company with the aim to uphold a required standard and exceed expectations in quality
In charge of preparation of validation activities associated with changing existing processes, implementing new processes and during development of novel products – maintain the Validation Schedule.
Preparation of process validation protocols for manufacturing method changes
Authoring validation protocols and reviewing of various compliance documentation
Qualifying manufacturing equipment (Equipment Validation) and critical utility systems used in the manufacturing facility
Leading Cleaning Validation
Proven experience with some Computer Validation is a bonus
Working with stakeholders such as Production and R&D Departments to ensure process validation scheduling and completion of validation documents
Reporting of results and any issues that may arise to Quality Systems Manager
Preparation of Regulatory Process Validation Reports
Participating in inspections that are performed by the TGA or other regulatory agencies
Implementing corporate policies through providing of procedures and supporting the practices necessary to maintain compliance with them – teach and train key stakeholders on validation
Show flexibility with working hours and support production schedule for smooth completion of validation activities.
The successful candidate will be a professional with at least five years’ experience in pharmaceuticals and able to demonstrate a history of participation in inspections performed by TGA and other regulatory agencies. To be shortlisted for consideration for this permanent role, you will have worked in similar positions and will have a detailed knowledge process, equipment, computer and cleaning validation in the pharmaceutical industry.
To be successful in your application you must meet the following criteria:
Possess a relevant tertiary qualification in Science such as Chemistry, Microbiology or Engineering
Have minimum of five years’ experience in similar role(s), specifically within the area of process validation in the pharmaceutical industry
Computer validation will be a bonus
Be knowledgeable of the regulatory guidelines applicable to the validation of equipment and its cleaning and manufacturing processes
Communicate through well-developed interpersonal skills, which engender teamwork and embody leadership qualities
Be familiar with GMP and its application in the pharmaceutical industry
Have the capability to critically evaluate documentation within a Validation Master Plan and writing skills necessary for revising components and drafting new content
Demonstrate the competency to monitor environmental conditions and conduct audits of areas of responsibility
Initiative and proactive approach – you must be able to work under minimal supervision
High attention to detail and strong writing skills will see you shortlisted
To discuss this excellent opportunity please call Daniel or Jo on 03 9516 0100. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.
Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.