Advisor (GMP Audit), Medsafe | Wellington
|Category:||Policy and Advisory|
|Position Type:||Ongoing - Full Time|
|Attachments:|| Advisor (GMP Audit), Product Safety Team, Compliance Management Branch, Medsafe - HSII.pdf (PDF, 187KB)
|Application Close Date:||01-Jul-2022|
- Fantastic team working in Medsafe
- Permanent role
- Wellington based only
Full time permanent position available for a candidate with experience in medicine manufacture, and / or aspects of the medicine supply chain. Your chance to develop your technical and problem-solving skills into practice by auditing manufacturers of therapeutic products.
Mō tō mātou rōpū – About our team:
The Compliance Management Branch sits within the Medsafe Group which is within the Health System Improvement and Innovation Directorate at the Ministry of Health. This directorate promotes innovation and continuous system improvement through quality commissioning and policy, effective regulation and evidence -based decision making. Medsafe specifically ensures that medicines have acceptable quality, safety, and efficacy.
Te whainga poto o tēnei tūranga – What is the purpose of this position?
The role of an advisor in the Product Safety Team, Compliance Management is to provide high technical advice on the regulation of medicines and provide quality advice in relation to the Code of GMP to the pharmaceutical manufacturing industry and the wider Ministry of health and other government agencies.
In this position you will conduct GMP site audits of medicine manufacturing and packing sites, against the New Zealand Code of Good Manufacturing Practice. Site audits are typically between one and five days in duration.
You will be required to review; risk assess and investigate reports of quality issues along with responding to complaints about advertisements for therapeutic products. You will support the medicine compliant and recall process, provide advice to suppliers, manufacturers & users of medicines and assist in taking regulatory action against non-compliant products.
An important part of this role will be your contribution to the implementation of projects and programmes as well as supporting continuous process improvement.
Ngā Pūkenga me ngā Wheako – Skills & Experience:
To be successful in this role you will have some experience in either medicine manufacture, and / or aspects of the medicine supply chain. You will have experience in GMP and possibly in an audit capacity. You are likely to have a sound technical knowledge of, and familiarity with, the manufacture of pharmaceuticals.
You will need to have high computer literacy skills and previous experience in applying critical thinking and using sound judgement. You will have experience, or have an interest in, working in a regulatory environment as well as having an interest in process improvement. In this position you will be able to manage your own workload, be willing to contribute to a peer review system, and work as part of a well-motivated team. A relevant technical tertiary qualification is required in an area of chemistry, pharmacy, engineering or a related discipline, have good computer skills and an interest in medicines.
This role is a Duel banded starting on 16G which has a salary range of $ 74,128 - $98,838. Offered salary will be based on candidate's skills and experience.
Ngā uaratanga - Our Ministry values
The Ministry of Health is the kaitiaki of the health and disability system in New Zealand. We are responsible for providing active stewardship and leadership across the nation's health and disability system. We ensure the system provides people with the highest levels of care, regardless of who they are or where they live.
You will find a copy of the Position Description attached or online at careers.health.govt.nz. Please click ‘Apply for this Job' to upload your CV and cover letter.
For further information regarding the role, please contact Deborah at firstname.lastname@example.org, quoting reference number MOH/1637820.
Advertising for this role closes at 6pm on Friday, 1st July 2022
We encourage diversity and inclusion at the Ministry of Health and are committed to equal opportunity in all our employment policies and procedures. In particular, we want to ensure accessibility needs are well supported, so the recruitment process is fair and equitable for all. Therefore, please let us know if there is any support, we can provide to ensure the recruitment process is fully accessible to you. You can contact us at email@example.com or on +6444665318 if you would like to discuss any accessibility needs you may have.