Operational and Quality Assurance Specialist

3 weeks ago

Auckland, Auckland, New Zealand Buen Pharma Full time

We are seeking a highly skilled Operational and Quality Coordinator to join our team at Buen Pharma. This is a permanent, full-time position that offers a competitive salary and opportunities for growth and development.

Job Summary

The Operational and Quality Coordinator will be responsible for ensuring the conformance of our products with quality standards and procedures, and that we are operating to a high standard of GMP, RMP, and other regulations for market access requirements. This includes conducting internal audits, verifying compliance, and implementing corrective actions.

The successful candidate will have a strong background in quality assurance and compliance, with experience in nutraceutical manufacturing and a proven ability to prioritize and manage multiple tasks. They will also have excellent communication and problem-solving skills, and be able to work effectively in a fast-paced environment.

Key Responsibilities
  • Verify the company's conformance with quality standards and procedures, and 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 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, and effective monitoring.
  • Ensure all declarations, permits, and regulatory approvals are managed effectively, and meet regulatory and company requirements.
  • Assist in quality compliance system review and follow-ups, including 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 and other quality system documentation.
  • Design and review product stability protocols, and conduct planning, experiments, and oversee process to collect test results and generate product stability reports.
  • Support the batch document changes.
  • Maintain technical specifications and testing parameters for laboratory experiments.
  • Ensure manufacturing process controls are correctly implemented.
  • Support product stability protocols, and conduct experiments and oversee process 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.
  • 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.
Requirements
  • Tertiary qualification in Business or Science/Engineering required.
  • Minimum of 3 years related working experience in nutraceutical/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.
  • Candidates must have no history of substance abuse, and must have a clean criminal record.

We offer a competitive salary, opportunities for growth and development, and a dynamic work environment. If you are interested in this position, please send your CV and cover letter to hr@buenpharma.co.nz.

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