Laboratory Regulatory Affairs and Compliance
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- Job Listing Date
- 8 Jul 2019
- Auckland, Auckland Central
- Work Type
- Full Time
- Science & Technology, Food Technology & Safety
Skills and Experience
Bachelor's degree in Science (required).
Knowledge of analytical methodologies used for quality control. (Desired)
Experience in the chemical, pharmaceutical or food manufacturing industry. (Desired)
Knowledge of GMPs and ISO standards for the pharmaceutical or food manufacturing industry. (Desired)
Experience in word processing and documentation system required. (required).
Excellent written skills in english (required).
Experience in the elaboration of technical documentation, standard operating procedures. (required).
- Studying scientific and legal documents.
- Recording of quality control information for product release documentation.
- Researching and collating documentation and information for technical product support.
- Gathering, evaluating, organising, managing and collating information in a variety of formats.
- Ensuring compliance with regulations set by the Industry to facilitate preparation of pre-market submission documents.
- Maintaining familiarity with company production ingredients, product ranges, technical information.
- Maintaining the information systems up to date for the Integrated Quality Management Systems. following the ISO9001:2015, ISO14001:2015 and ISO45001.
- Keeping up to date with changes in regulatory legislation and guidelines
- Usage of computer applications in the field of quality control, word processing and cloud systems.
- Liaising and negotiating with providers and regulatory authorities.
- Writing comprehensible, user-friendly, clear SOPs and information systems for the lab assistant working in the production line.
- Ensuring that documentation and quality standards for production are constantly met.
- Which of the following statements best describes your right to work in New Zealand?
- Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?
- What's your highest level of education?