Validation Manager
4 weeks ago
**- **Job no**:493900**
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- **Business unit**: DoseAid Pty Ltd, ABN 55 129 958 934**
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- **Position location**: Mansfield**
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- **Work type**:Full Time Permanent**
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- **Location**:QLD - Brisbane****:
**Validation Manager - DoseAid, Brisbane QLD**
**About us**:
DoseAid provides a simple, safe and convenient way to managing your medicines and vitamins.
DoseAid is a subsidiary of the EBOS Group. With almost 5,000 employees in 109 locations across Australia, New Zealand, and Southeast Asia, EBOS Group is the largest and most diversified Australasian marketer, wholesaler and distributor of healthcare, medical and pharmaceutical products. It is also a leading marketer and distributor of recognised animal care brands.
EBOS Group is publicly listed on the New Zealand and Australian stock exchanges.
**The opportunity**:
The Validation Manager will be responsible for defining, creating, and executing validation processes for all existing and new equipment, ensuring the processes are in line with best practice and evolving regulatory expectations.
**What you will do**:
- Lead and manage our validation and requalification programmes, examining current validation processes and recommending improvements.
- Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas.
- Responsible for oversight and execution of validations for production, manufacturing and cleaning processes.
- Develop/review and approve validation protocols and final reports and ensure compliance with cGMP and current regulatory requirements.
- Define, support and guide validation activities.
- Responsible for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities, and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards.
- Review change requests for impact to validation and support QA compliance activities such as Product Quality Review.
- Maintain Revalidation Plan and all manufacturing, while ensuring all revalidation is performed and reported.
- Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility.
**What we are looking for**:
- Tertiary qualifications in Science, Engineering, or related discipline
- Thorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle Approach.
- Experience in Process Validation execution and Equipment Qualification.
- Preferred experience in Cleaning Validation, Utilities Qualification and Computerised Systems Validation
- Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards.
**Why us?**
This is a unique opportunity to work in a company where you are valued, given the recognition you deserve and suitably rewarded for your hard work.
Other benefits include:
- Employee Share Plan
- Company Paid Parental Leave
- Employee Assistance Program for Mental Health Wellbeing
- Staff Awards
- Employee Referral Program
- Health Insurance Discounts
- And More
- Working in our state-of-the-art, purpose-built facility, built to GMP standards.
- Flexible working options including hybrid working model and flexible start and finish times (within reason)
EBOS Group are committed to developing and creating an inclusive workplace that embraces and celebrates diversity and inclusion.
**Applications close**: 27th Feb 2023
**Advertised**:13 Feb 2023 12:00 AM **E. Australia Standard Time**:
**Applications close**:27 Feb 2023 **E. Australia Standard Time
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