Operational and Quality Coordinator

2 months ago


East Tamaki, New Zealand Buen Pharma (NZ) Ltd Full time

**Operational and Quality Coordinator**

**Location: Auckland**

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.
- 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

**KPI**:

- Achieve minimum 95% DIFOTIS
- Fix production schedule 3 days before dispensing date
- Zero inventory write off or wastage due to wrong material planning and/ or production planning
- Effective and efficient quality systems in place. No overdue documentation
- 100% report on time with accurate info
- This is not a conclusive list

**REPORTING**:

- Submit weeking summary against above mentioned areas (including DIFOTIS, schedule delay and reasons, number of batches require reprocess/rework, OSS, etc)
- Report summary quality monitoring
- Any other report as and when required by the company

Your flexibility is required to support the continuous growth of the company.

**T



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