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Operational Quality and Compliance Specialist

2 months ago

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

We are seeking a highly skilled Operational Quality and Compliance Specialist to join our team at Buen Pharma. The successful candidate will play a crucial role in ensuring the quality and compliance of our products, while also driving operational excellence.


Key Responsibilities:

  • Verify conformance with quality standards and procedures, and ensure compliance with GMP, RMP, and other regulations.
  • Conduct internal audits and reality checks, and follow up on corrective actions and audit report closure.
  • Assist with external audits and follow up on identified issues in audit reports.
  • Perform risk assessments to ensure compliance and quality.
  • Drive robust root cause analysis and effective implementation of corrective and preventative actions.
  • Ensure effective management of declarations, permits, and regulatory approvals.
  • Assist with quality compliance system review and follow-ups.
  • Prepare, review, and update standard operating procedures and quality system documentation.
  • Design and review product stability protocols.
  • Maintain technical specifications and testing parameters.
  • Ensure manufacturing process controls are correctly implemented.
  • Provide technical support to the manufacturing team.
  • Ensure all personnel are working to plant safety standards.
  • Follow health and safety requirements and have relevant training.
  • Ensure confidentiality of obtained information and adhere to company policies and standards.
  • Assist with supplier approval and qualification programs.
  • Manage various projects and validation work as required.
  • Suggest methods for improving product quality or design, or manufacturing processes.
  • 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.

Requirements:

To be considered for this position, you will need:



  • Tertiary qualification in Business or Science/Engineering.
  • Minimum of 3 years related working experience in Neutraceutical/Food production, manufacturing compliance, and quality assurance.
  • 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.
  • Candidates must have no history of substance abuse and must have a clean criminal record.

What We Offer:

We offer a competitive salary and benefits package, including paid fortnightly, 4 weeks annual leave, statutory holidays, sick and bereavement leave, and opportunities to upskill.


How to Apply:

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