Operational Quality Coordinator

5 days ago

Auckland, Auckland, New Zealand Buen Pharma Full time
Job Title: Operational And Quality Coordinator

We are seeking a highly skilled and experienced Operational and Quality Coordinator to join our team at Buen Pharma. As a key member of our operations team, you will play a critical role in ensuring the quality and compliance of our products.

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 regulatory requirements.
  • Conduct internal audits and reality checks at the specified intervals, and follow up on corrective actions and audit report closure.
  • Assist in direct involvement with external audits and follow up on identified issues in audit reports.
  • Perform risk assessments of activities to ensure a high standard of compliance and quality.
  • Drive robust root cause analysis and effective implementation of corrective and preventative actions.
  • Ensure all declarations, permits, and regulatory approvals are managed effectively and meet regulatory and company requirements.
  • Assist in quality compliance system reviews and follow-ups, including deviation reports, non-conformances, equipment maintenance records, and corrective and preventative action plans.
  • Prepare, review, update, and maintain standard operating procedures and quality system documentation.
  • Design and review product stability protocols, conduct experiments, and oversee processes to collect test results and generate product stability reports.
  • Support batch document changes and maintain technical specifications and testing parameters for laboratory experiments.
  • Ensure manufacturing process controls are correctly implemented and provide technical support to the manufacturing team.
  • Ensure all personnel are working to plant safety standards and follow health and safety requirements.
  • Ensure confidentiality of obtained information and adhere to company policies and standards.
  • Assist in supplier approval and qualification programs, manage various projects and validation work, and coordinate with various parties to ensure order deliveries hit DIFOTIS.
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.
  • Knowledge and experience in HACCP and ISO standards.

If you are a motivated and experienced professional looking for a new challenge, please submit your CV and cover letter to hr@buenpharma.co.nz.

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