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Quality Assurance/supply Chain Manager

2 months ago

Chatswood, Australia Medison Pharma Full time

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases._
- Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets. _
- Medison is rapidly growing in the international markets backed by 30 years of established operations in Israel, global infrastructure, and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across the Baltics, Central and Eastern Europe, the Balkans, Greece as well as Canada, Australia and LATAM._

The QA/SA Manager Australia will be an experienced professional and part of Australian team. Based in Sydney the QA/SC Manager will support Australia and New Zealand and will report directly to the Head of QA and Supply Chain APAC. He/she will play a vital role in the local business across multiple functions.

**Requirements**:

- Bachelor’s Degree in science or equivalent
- At least 3 years’ experience in an active QA role or similar
- Supply Chain and Customer service experience desirable
- Excellent written and verbal communication skills
- Fluent English is essential
- Attention to detail
- Quality function representative on various projects
- Root cause analysis and investigation skills
- Technical report writing
- Strong knowledge in regulatory, cGDP and cGMP requirements
- Experience in auditing and quality systems
- Experience in regulatory inspections is desirable
- Strength in critical thinking, problem solving, and decision making
- Collaborative nature, self-directed and independent
- Strong organizational abilities
- Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships
- Works effectively in highly dynamic and changing environments, displays agility
- Willing to travel locally and internationally as needed
- Ability to work with anyone (flexible personality) horizontally and vertically across the organization with a demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutions
- Be a quick learner with strong work ethics
- Be pragmatic with a drive for results
- Ability to identify and understand issues, problems and opportunities whilst providing a viable solution
- Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected cons

**Responsibilities**:
**Areas of Responsibility**
- Participate in designing, implementing, maintaining, and improving local and global quality system.
- Ensure the local QMS is compliant and suitable to support the local business
- Independently initiate and approve SOP updates and creation of new SOPs. Additionally oversee review of SOPs and associated documentation to ensure review requirements are met.
- Provide hands on quality expertise to colleagues and partners to support their quality and business needs.
- Participate in vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipment.
- Work with Head of Supply Chain and Quality to ensure Medison is compliant with latest regulatory and pharma trends related to GDP (and GMP as required)
- Ensure/participate in self-inspections of Medison GDP operations are performed to schedule and identified CAPA’s are closed to plan.
- Participate in Medison Management Review to assess the effectiveness of the QMS and to highlight continuous improvements as appropriate.
- Participate in GDP Vendor Management reviews, provide oversight and partner with Distributors to ensure compliance to Quality agreements (internal/ vendor and partner
- Ensure change control requests, deviations, complaints and CAPA’s are reviewed using risk-based principals to comply with applicable requirements.
- Participate in regulatory inspections and supplier audits as required.
- Manage local and participate in global initiated recall and mock recall operations.
- This role will also involve supporting all function but specifically quality, supply chain and carrying out customer service activities as required.
- Carry out any other duties that maybe reasonably required and assigned to you by your manager

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