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Quality and Technical Officer

4 months ago

New Zealand Alpha Laboratories NZ Ltd Full time

**Job Title: Quality and **Technical Officer**

**Location: Auckland**

The role is to focus on ensuring ongoing compliance with all relevant regulatory bodies and company standards. Assisting in the implementation and improvement of Quality standards within Alpha. Proactively drive a culture of GMP and RMP compliance for prevention.

This role will be a permanent, full-time position and will be guaranteed 40 hours of work per week. You will be paid 29.66-30.00 per hour depending on your experience and skill level. Paid fortnightly, 4 weeks annual leave, Statutory holidays, Sick and bereavement leave. Opportunities to upskill.
- To verify the companys conformance with Quality standards and procedures, and that they are operating to a high standard of GMP, RMP (animal and dairy) compliance and other regulation for market access requirements.
- Conduct Internal Audits and reality checking at the intervals specified in the SOP and follow up in the completion of corrective actions and audit report closure.
- Assist in direct involvement with external audits and follow up the identified issues in audit report.
- Perform Risk assessment of any activities, as required, in order to ensure a high standard of compliance and quality.
- Proactively drive robust root cause analysis and effective implementation of corrective and preventative actions and effective monitoring.
- Ensure the compliance of the legal requirements of the transitional facility, container inspections, load in and out.
- To ensure all declarations, permits and regulatory approvals (e.g. eligibility documents, Health certificates etc.), OMAR including for market labels, are managed effectively, and meeting regulatory and company requirements.
- Assist in quality compliance system review and follow ups, including but not limited to: Deviation Reports (DRF), non-conformances (NCR), Equipment Maintenance Record (EMR), Change Control Request Form (CCRF), Customer Complaint Report (CCR), Product Quality Review (PQR) and Corrective and Preventative Action Plan (CAPA) in a timely manner.
- Prepare, review, update and maintain Standard Operating Procedure or other quality system documentation and ensure that this is done accurately, to the required standard, and in a timely manner.
- To support the batch document changes and mastering and BOM creation.
- Create and maintain technical specifications and testing parameters for laboratory experiments to ensure the incoming samples for raw materials, bulk intermediates, stability, validation and finished products are tested for parameters with techniques which meet the critical requirements of technical manufacturing needs, target market and regulatory requirements.
- Review and improve the formulations and manufacture processes by making technical assessment and to ensure manufacturing process controls are correctly implemented.
- Design and review product stability protocols by carrying out planning, conducting experiments and overseeing process to collect test results and generate product stability report.
- Formulate and approve potency adjustments and calculations for technical specifications, product, materials, packing instructions.
- Provide technical support to the manufacturing team and troubleshoot any issues that may arise during production.
- Ensure confidentiality of obtained information and adhere to company policies and standards.
- Assist in managing returned goods, return to customer of reprocessed goods and reject management.
- Assist in supplier approval and qualification programme.
- Assist and manage various projects and validation work and calibration as and when required by the company.
- Suggest methods for improving product quality or design, or manufacturing processes, to help develop a company culture based on continuous improvement.
- Project and/or special areas of responsibility as delegated by the company.

**To be considered for this position**:

- Teritary qualification in Food Science, Nutrition, Biotechnology, Chemistry, Pharmacology or equivalent is an advantage
- Minimum of 3 years related working experience:

- in Pharmaceuticals/Food product manufacturing compliance and technical specification reviews
- in risk assessment and analysis, compliance audits, material and product specification set up according to the market regulatory limit
- Experience in food manufacturing requirements within a production environment for exports would be ideal.
- Proven ability to prioritize and effectively manage multiple tasks while under pressure.
- High attention to detail, positive solution-focused attitude, and strong drive for improvement.
- Excellent verbal and written communication skills and computer literacy skills.
- Perform tasks in a methodical and thorough manager within scheduled timeframe.
- Knowledge and experience in HACCP, GMP and ISO standard.