Outsource your QA
OZQA Quality Office gives you flexible access to experienced Quality professionals who can support the day to day operation of your QMS, manage Quality activities and help your organisation stay ready for what comes next. From a few hours of ongoing support to a broader outsourced Quality function, we adapt the setup to your organisation, activities and internal resources.
ONE MODEL DOESN'T FIT EVERY ORGANISATION
Your Quality Office can grow with you.
Quality workload is rarely constant. A development milestone, supplier audit, inspection, certification project or significant Quality issue can temporarily increase the workload dramatically. At other times, only routine QMS maintenance may be required. An outsourced model allows the level of support to change as your needs change.
QUALITY SUPPORT
QA OFFICE
Add capacity to your existing team.
You already have internal Quality expertise but need additional resources for selected activities or during busy periods. OZQA works alongside your existing team.
Ideal for:
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Organisations with an existing QA function that need additional capacity.
Typical support
Document management
Training administration
Supplier Quality
CAPA follow up
Quality records
Audit preparation
FRACTIONAL QA
QA OFFICE
Quality without a full time hire.
Get regular access to an experienced Quality professional who understands your organisation and supports agreed Quality responsibilities on an ongoing basis.
Ideal for:
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Organisations that need quality support but do not yet require a full time senior QA resource.
Typical support
QMS oversight
Quality decisions
Supplier oversight
Risk and change activities
Management Review
Audit and inspection readiness
FLEXIBLE QUALITY SUPPORT
Add quality capacity without adding headcount.
Quality requirements often grow faster than the organisation. A company may need supplier qualification, document control, training, CAPA management, Quality reviews and audit support long before there is enough work to justify hiring specialists for every area. OZQA can become an extension of your organisation and provide the Quality capacity you need, when you need it. You keep control of your organisation and business. We provide the additional Quality expertise and operational support.
WHAT CAN WE TAKE CARE OF?
From QMS maintenance to daily quality operations.
Quality systems often grow one document at a time. New procedures are added, responsibilities change, suppliers increase and regulatory requirements evolve. Over time, this can create duplication, inconsistent processes and unnecessary administration.
CRO
Clinical trial partners
Quality oversight of outsourced clinical activities
CDMO
Development & manufacturing partners
Quality oversight across development, manufacturing and supply.
Laboratories
Testing & analytical partners
Qualification and ongoing oversight of external laboratories.
Distributors
Distribution partners
Quality oversight throughout the distribution network.
Critical Suppliers
High impact suppliers
Risk based qualification, monitoring and Quality follow up.
Service Providers
External specialist partners
Structured qualification and oversight of outsourced services.
WORK WITH YOUR EXISTING PARTNERS
Outsourced activities still require oversight.
For many pharmaceutical, biotech and MedTech organisations, significant activities are performed by external partners. Your Quality Office can support Quality activities across your external network and help maintain appropriate oversight.
NO NEED TO START AGAIN
Keep your system. Add the expertise.
You do not need an OZQA built QMS to use our outsourced Quality services. We can work within your existing Quality Management System, procedures and technology. Where improvements are needed, we can recommend changes and help implement them. Where the system already works, we simply operate within it.
QUALITY REQUIREMENTS ARE NOT THE SAME EVERYWHERE
Quality support matched to your regulatory environment.
Instead of relying on one consultant for every Quality question, your organisation can access different expertise depending on the activity. Your primary OZQA contact can coordinate the ongoing Quality work while relevant specialists are brought in when required.
Pharma & Biotech
Quality support across development and commercial activities, including GxP processes, supplier oversight, clinical quality and milestones preparation.
Medical Device
Support for ISO 13485 quality management systems, supplier quality, risk management, documentation, audits and ongoing QMS operation.
Cosmetics
Practical quality and compliance support for organisations developing, manufacturing and placing cosmetic products on the market.
Other industries
Flexible quality support for organisations operating or preparing to operate structured and regulated ISO 9001 aligned quality management systems.
FROM A FEW HOURS TO A QUALITY FUNCTION
You don't need to outsource everything.
You may only need help maintaining training records today. In six months, you may need supplier audits, CAPA management and inspection preparation. Later, you may hire an internal Quality Manager and use OZQA only for specialist support. The model can evolve with your organisation.
CONNECT WITH OTHER OZQA SERVICES
Quality solutions built around where you are.
OZQA combines proven quality frameworks, ready-to-adapt documentation and experienced Quality professionals to help you move forward without starting from scratch. Choose the solution that fits where you are today.
Build QMS
Starting from scratch or preparing for your next development stage? Use established frameworks and quality content to get you operational faster.
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Improve QMS
Keep what works. Fix what does not. We identify quality gaps, simplify processes and strengthen your existing quality management system.
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Digitalise QMS
Turn document control into structured digital workflows with approval, traceability, notifications and connected Quality processes.
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PREFER TO IMPLEMENT IT YOURSELF?
Start with our ready made Quality documentation.
If you already have the Quality expertise and resources required for implementation, you can purchase individual Quality documents or complete documentation packages without implementation support.
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