Validation Associate

5 months ago

Prestons, Australia PharmaCare Group Full time

**Introduction**:
About us

At PharmaCare, we inspire people to be the best, healthiest and happiest they can be. As an Australian born and built success story we are proud of our heritage and remain a 100% Australian owned and family operated business. We are home to some of Australia’s most well-known and trusted brands including Nature’s Way, Bioglan, Sambucol, Norsca, Brut, Skin Doctors, Naturopathica, KP24, Aquasun, Promensil, BioMedica, Medlab and many more.

PharmaCare has tripled its work force and production output over the last 3 years. Our rapid growth has seen massive investment committed to our operation with $20M planned over the next 24 months. Recent developments have seen the operation double its footprint with further expansion on the horizon.

Our success comes from our performance led culture, and we want our people to succeed. We encourage ownership and integrity with an entrepreneurial flair. Based in Prestons, we live the life we promote.

We are family owned with a global reach, our products are found in pharmacies, supermarkets, department and variety stores all over the world.

**Extras we know you’ll love**:

- Generous monthly complimentary products to support your health and wellbeing
- Paid parental leave, subsidised health and salary continuance insurance
- Employee assistance/wellbeing initiatives
- Ongoing training and development programs
- Secure onsite parking
- Work life balance - knowing “downtime” is as important as “uptime”
- Leave loading.

**Description**:
About the role

PharmaCare Operations is looking for a Validation Associate to be responsible for the Validation of processes and equipment used within PharmaCare Operations (DQ, IQ, OQ & PQ). This role requires knowledge of current GMP requirements with regards to the documentation and validation; with a large focus on drafting, owning, executing, reviewing and reporting validation documents for PharmaCare Operations.

Reporting to the Validation Manager, your key responsibilities include but are not limited to:
Preparing and executing Validation protocols.
Preparing and updating Validation documents.
Participating in and documenting Validation and compliance Risk Criticality Assessments.
Review and analyse qualification or validation data/results.
Prepare Validation Reports.
Maintain records and files of validation work.
Become familiar with production processes and methods by building productive relationships with Production, Engineering, Maintenance and Quality.
Observe production, developmental and experimental activities to understand detailed operating procedures and methods to create effective Validation protocols.
Recommend Changes to the manufacturing processes to enhance and improve efficiencies.
Provide support to small and medium sized operational projects as required.
Provide support to operational investigations related to equipment and process failures.
Perform Validation Reviews, Re-Qualification or Re-Validation; to maintain all validated systems in their validated state.
Assist in the management of Validation Register/Database.
Assist on other appropriate Validation tasks, as required.

**Skills and Experiences**:
About you
- Manufacturing background with minimum of 3-5 years’ experience in Pharmaceutical (preferred)
- Proven skills in GMP technical writing, e.g. Validation plans, protocols and reports
- Validation experience in a GMP environment and ability to interpret the Australian Code of GMP
- Time management, analytical and problem-solving skills
- Driven and energetic personality
- High level of attention to detail, initiative, and strong work ethic
- Strong communication skills both written and verbal
- Commitment to Continuous Improvement

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