Validation Manager
5 months ago
**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 Manager to manage validation activities for our TGA licensed manufacturing facility.
Reporting to the Head of Quality, your key responsibilities include but are not limited to:
Managing validation staff
Maintaining site validation master plan
Preparing URS for new equipment and facilities
Preparing and executing process validation protocols
Preparing and executing cleaning validation protocols
Preparing and executing equipment qualification protocols (DQ/IQ/OQ/PQ)
Preparing and executing software validation protocols where required
Maintaining all validation records
Conducting risk assessments
Assisting with engineering studies
Liaising with manufacturing areas to ensure validation activities align with production schedules
Supporting manufacturing areas with root cause analysis investigations
Any other appropriate tasks, as required.
**Skills and Experiences**:
About you
5+ years Validation Management experience in a TGA/GMP pharmaceutical manufacturing environment.
Tertiary qualifications in a Science or Engineering related discipline
High level of attention to detail, initiative, and strong work ethic
Strong communication skills both written and verbal
Ability to work collaboratively within a team and other internal departments
Commitment to Continuous Improvement
Time management, analytical and problem-solving skills
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