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.
- 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
- 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
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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.