Hikurangi Cannabis Job Vacancy: GMP & Quality Assurance Specialist

Hikurangi Cannabis is dedicated to bringing cannabis-based therapies for unmet medical needs to patients. Each position is directly or indirectly responsible for improving the lives of people with serious health conditions.
As the first, and currently only, company in New Zealand to hold a license to cultivate medicinal cannabis plants, Hikurangi is in the process of constructing a purpose-built pharmaceuticals manufacturing facility near Ruatoria.
Our GMP & Quality Assurance Specialist will work with the company management team and a group of specialist consultants designing the GMP processes Hikurangi use to manufacture medicines.
The role will subsequently oversee the day-to-day operations of the Quality Management System, including but not limited to deviations, Corrective and Preventive Actions, investigations, excursions, Out of Specifications, change control, batch review and disposition, data integrity, and training colleagues involved with our medicinal cannabis manufacturing.

 

Key result areas (major duties, accountabilities and responsibilities):

  • Co-design cGMP processes and facilities.
  • Oversee implementation of cGMP processes.
  • Coordinate training of new manufacturing and quality assurance teams.
  • Manage manufacturing operations through administration and enforcement of the GMP compliant Quality Management System.
  • Review and approve batch records.
  • Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
  • Review and approve preventative maintenance, calibration, and work order documentation.
  • Facilitate internal audits and support external audits.
  • Support the supplier quality program through review and approval of vendor change notifications, raw material specifications, and raw material release.
  • Review, assist in the investigation of, and approve environmental excursions.
  • Provide on-the-floor QA support for manufacturing activities.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.
  • Contribute to standard-setting for the company and the New Zealand medical cannabis industry, working closely with counterparts in other organisations in New Zealand and internationally.

Minimum Qualifications:

  • A minimum of a Bachelor’s degree in Life Sciences or Engineering
  • At least five years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
  • Experience working in a GMP manufacturing environment
  • Well versed in cGMP regulations and guidelines
  • Applicants must be able to demonstrate ability to gown aseptically

Core competencies:

  • Strong communication skills
  • Strong organisational skill
  • Strong leadership skills
  • Attention to detail and highest standards
  • Capable of working with minimal supervision
  • Ability to work well with diverse groups and manage teams
  • Ability to manage multiple activities with challenging timelines

– – –

If you meet the Minimum Qualifications listed above, please complete the following form. Expressions of interest will be short-listed and the most promising individuals invited to apply for the position. Expressions of interest in this role are invited until 7 November 2018 and will be treated in strict confidence. 

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