October 16, 2024

Buen Pharma (NZ) Ltd

East Tamaki

FULL TIME

Operational and Quality Coordinator

Operational and Quality Coordinator

Location: Auckland

We are looking to hire Operational and Quality Coordinators. We are a nutraceutical manufacturing company with a manufacturing facility at East Tamaki , Auckland. This position is based at one location, but candidates must be prepared to provide quality, technical and operational support at other sites when required.

The role is to focus on co-ordinating and supporting cross-functionally across the business’s operations to achieve optimum and meeting customer expectation, as well as ensure innovation and continuous improvement of Quality Assurance and operation.
This role will be a permanent, full-time position and will be guaranteed 40 hours of work per week. You will be paid an hourly rate of $29.66-$30.00 depending on your experience and skill level. Paid fortnightly, 4 weeks annual leave, Statutory holidays, Sick and bereavement leave. Opportunities to upskill.
Candidates need to be able to start immediately and work lawfully in New Zealand.

Successful Candidates are expected to:

To verify the company’s conformance with Quality standards and procedures, and that they are operating to a high standard of GMP, RMP (animal and dairy) compliance and other regulations 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 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.

Design and review product stability protocols by carrying out planning, conducting experiments and overseeing process to collect test results and generate product stability report.

Support the batch document changes.

Maintain technical specifications and testing parameters for laboratory experiments to ensure the incoming samples for raw materials, bulk intermediates and finished products are tested for parameters with techniques which meet the critical requirements of technical manufacturing needs, target market and regulatory requirements.

Ensure manufacturing process controls are correctly implemented.

Support product stability protocols by conducting experiments and overseeing process to collect test results

Plans and schedules production, packing and/or outbound shipments

Performs necessary operation/production activities to ensures daily production operation running smoothly

Provide technical support to the manufacturing team and troubleshoot any issues that may arise during production.

Ensures all personnel are working to plant safety standards.

Follows health and safety requirement and has the relevant training to conduct the role, and be aware of all identified hazards, which are associated.

Ensure confidentiality of obtained information and adhere to company policies and standards.

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.

Ensure accurate record keeping of inventory and maintain the ERP system

Coordinate with various parties to ensure order deliveries hit DIFOTIS

Monitor incoming orders and plan to secure enough materials at the right time

Release raw materials and finished products under delegated authority

Monitor conformance of pest control program, hygiene and sanitation program, environment, and pathogen monitoring programmes.

Project and/or special areas of responsibility as delegated by the company

To be considered for this position:

Tertiary qualification in Business or Science/Engineering required
Minimum of 3 years related working experience in Neutraceutical/Food production, manufacturing compliance and quality assurance and technical specification.
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 and ISO standard.