Quality Associate - Validation (Pharmaceutical Manufacturing)

 Quality Associate – Validation

At Life-Space Group, it’s our mission to make the latest scientific advances in the microbiome available to all and lead the way in Probiotics supplementation. Our hero brand, Life-Space, is a leader in the global probiotic industry. Launched in 2012, Life-Space is passionate about unlocking the possibilities of the microbiome and empowering people of all ages to sustain and achieve long-term health.

We are looking for a Quality Associate – Validation to join our Life-Space Group team. Reporting to the Senior QA Associate, this role plays an integral part in the Validation/Quality teams in preparing, reviewing, and executing validation protocols. You will work closely with our Quality and Production teams on validation activities for LSG.

Key outcomes of the role include: 

• Participate in the preparation, review and approval of Validation Policy, Validation Master Plan, validation SOPs, DQ, IQ, OQ, PQ, PV protocol and URS templates, as required.
• Provide documented justifications whether formal risk assessments to be performed or not for validation activities if RA to be performed apply Quality Risk Management tools available at BioCarna’s PQS system to all validation activities. 
• Execute validation protocols and activities in liaison with production, QC, maintenance team as required Submit validation samples to relevant teams, such as quality, supply chain and/or operations for final assessment and approval to be able to proceed to a next step of validation activity/documentation in a timely manner.
• Assist with laboratory submission forms of test samples. Collate, review, analyse, capture factual and accurate data in validation reports. 
• Work with key stakeholders such as Production, Supply Chain and NPD to ensure validation scheduling and completion of validation activities and documents.
• Participate in cross-team activities e.g. investigations, risk assessments as appropriate
• Assist with deviations, Out of Specification investigations, Change Requests, root cause analyses and risk assessments, related to validation activities.
• Ensure the Validation Schedule Matrix updated as validation activities and documents completed since this Matrix is an on-going working document.
• Maintain an electronic filing system of all Validation and Quality documents.

 As the successful candidate, you will have;

• 3-5 years’ experience in pharmaceutical or complementary medicines industries, mainly in the areas of manufacturing, validation and/or quality assurance.
• Tertiary qualifications in science, engineering, medical, health or life sciences desirable
• Knowledgeable of the guidelines applicable to the validation of facilities, utilities, equipment, process, cleaning, and computer systems requirements.
• Strong working Knowledge of the current cGMP and PIC/S guide, including industry guidelines.
• High level of interpersonal, time management and organisational skills.
• Knowledge and/or hands-on experience in end-to-end manufacturing processes, functional requirements of facilities, utilities, equipment, and computer systems highly regarded
• Cross functional problem solving and decision making.
• Excellent verbal and written communication skills.

In return, you will receive:

• Competitive salary with Yearly Bonus Incentive Program
• The opportunity of working for a well-established, energized, and rapidly growing organisation.
• Range of competitive employee benefits including a paid parental leave program
• Option to work Hybrid with 1 day WFH
• Access to LinkedIn Learning
• Access to flu vaccines, skin checks & healthy heart checks yearly 
• Options to purchase additional leave
• Salary packaging & novated lease options
• Family and Friends quarterly product allowance across the Life Space product range- $1000 of free products each year 
• Benefits and eligibility listed may vary depending on your position and location and may be subject to change

If this is you please click the "Apply now" button below and include a covering letter with your application. 

Please understand that due to the volume of applications we receive only short-listed candidates will be contacted.