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Quality & Regulatory Compliance Team Lead

Quality & Regulatory Compliance Team Lead

Technical Recruitment Solutions LtdWaitematā, Auckland, New Zealand
28 days ago
Job description

Overview

Quality & Regulatory Compliance Team Lead at Technical Recruitment Solutions Ltd. Onsite role in central Auckland. Responsible for ensuring GMP, GLP and regulatory standards are met, while overseeing operational excellence and product quality within the QRC team.

About the Company

Dedicate your quality & regulatory compliance expertise to a company whose products make a direct impact on the lives of New Zealanders. A New Zealand–owned and operated pharmaceutical manufacturer with over 25 years of experience producing intravenous, aseptic, and non-sterile products. Known for fast-paced operations and a strong commitment to continuous learning and development.

Responsibilities

  • Leading the review of documentation for finished products and making timely release decisions
  • Overseeing batch document reviews for aseptic department products
  • Managing reject systems : raising notes, maintaining logs, and ensuring SOP compliance
  • Handling customer complaints and conducting investigations
  • Performing and delegating internal audits, preparing reports, and implementing corrective actions
  • Managing the change control process
  • Leading deviation and quality investigations, identifying root causes, and initiating corrective actions
  • Commissioning and decommissioning production equipment
  • Authorising master documents, regulatory quality documents, and SOPs
  • Reviewing and authorising validations of equipment, processes, and facilities
  • Preparing trend reports on deviations, sterility testing, and environmental results

Working Hours

  • Tuesday - Friday : 12.00pm – 8.30pm
  • Saturday : 9.00am – 5.30pm
  • Candidate Profile

    The ideal candidate will have strong knowledge of GMP and regulatory systems, substantial experience in pharmaceutical / sterile manufacturing, and excellent attention to detail. Leadership experience is advantageous but not essential, with a supportive and growth-focused manager.

  • A degree in chemistry, microbiology or related scientific discipline is essential.
  • Excellent knowledge of GMP
  • A minimum of 5 years demonstrated experience in a quality / compliance related role within a pharmaceutical or sterile manufacturing.
  • A proactive and resourceful approach to learning and research
  • Strong communication skills and ability to communicate cross-functionally
  • Proven analytical and problem-solving skills
  • How to Apply

    To apply for this role, please select the relevant ‘Apply’ button. Alternatively, contact Maya Carpenter-Salvador at with a copy of your CV.

    We look forward to hearing from you!

    #J-18808-Ljbffr

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    Compliance Team Lead • Waitematā, Auckland, New Zealand

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