Operational Quality Assurance Specialist

7 days ago

Auckland, Auckland, New Zealand Buen Pharma Full time
Job Title: Operational Quality Assurance Specialist

About the Role:

We are seeking an experienced Operational Quality Assurance Specialist to join our team at Buen Pharma. As an Operational Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products, as well as supporting the operations team in achieving our business objectives.

Key Responsibilities:

* Verify the company's conformance with quality standards and procedures, and ensure that we are operating to a high standard of GMP, RMP, and other regulations for market access requirements.
* Conduct internal audits and reality checking at the intervals specified in the SOP, and follow up on the completion of corrective actions and audit report closure.
* Assist in direct involvement with external audits and follow up on the identified issues in the audit report.
* Perform risk assessments of any activities, as required, 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 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, non-conformances, equipment maintenance records, change control request forms, customer complaint reports, product quality reviews, and corrective and preventative action plans.
* Prepare, review, update, and maintain standard operating procedures 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 processes to collect test results and generate product stability reports.
* 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 that 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 processes to collect test results.
* Plan and schedule production, packing, and/or outbound shipments.
* Perform necessary operation/production activities to ensure daily production operations run smoothly.
* Provide technical support to the manufacturing team and troubleshoot any issues that may arise during production.
* Ensure all personnel are working to plant safety standards.
* Follow health and safety requirements and have the relevant training to conduct the role, and be aware of all identified hazards associated.
* Ensure confidentiality of obtained information and adhere to company policies and standards.
* Assist in supplier approval and qualification programs.
* 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 programs, hygiene and sanitation programs, environment, and pathogen monitoring programs.
* Project and/or special areas of responsibility as delegated by the company.

Requirements:

* 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 manner within scheduled timeframes.
* Knowledge and experience in HACCP and ISO standards.

What We Offer:

* Competitive hourly rate of $29.66-$30.00 depending on experience and skill level.
* Paid fortnightly, 4 weeks annual leave, statutory holidays, sick and bereavement leave.
* Opportunities to upskill.
* A dynamic and supportive work environment.

How to Apply:

If you are interested in applying for this role, please send your CV and cover letter to hr@buenpharma.co.nz

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