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Opella

Global OTC & VMS self-care manufacturer

Quality Officer - Analytical Chemist

Regulatory & Quality (Life Sciences)Updated on Nov 14
Full-timeBrisbane QLD, AustraliaNo salary listedIn-person

About the Job

Requirements

  • A Certificate/Diploma or bachelor’s degree in a science discipline is required.
  • One to three years of laboratory experience is required; a quality assurance background is preferred.
  • Ability to express ideas clearly and concisely in spoken and written communications.
  • Working knowledge of method validation principles under ICH Q2(R2), and verification under USP <1226> when adopting compendial methods.
  • Awareness of instrument qualification concepts under USP <1058>, and good manufacturing practice (GMP), PIC/S, and ALCOA+ behaviors in routine testing.
  • Basic proficiency with LIMS and SAP, and awareness of Release for Supply (RFS) for Australian supply.
  • Knowledge of data integrity (ALCOA+) and audit trail controls in accordance with TGA data-integrity expectations and PIC/S data-integrity guidance, and workplace health and safety (WHS) basics for hazardous chemicals.
  • Knowledge of LIMS data entry and chain-of-custody practices under ASTM E1578-18, and document control basics under PIC/S Chapter 4.

Responsibilities

  • Execute sample receipt and booking; maintain chain-of-custody records and registers, perform second-person reviews when needed, and own key quality documents.
  • Coordinate stability logistics and external testing shipments and documentation; track turnaround and issues.
  • Assemble Certificates of Analysis (CoA) packs, perform LIMS approval when needed, update master data in LIMS and controlled documents, and support training coordination.
  • Contribute to health, safety and environment (HSE) activities and safe laboratory practices.
  • Lead and contribute to laboratory investigations and implementation of quality-event actions.
  • Troubleshoot methods and instruments; support method validations and transfers, and system suitability.
  • Raise and own quality records, including deviations and out-of-specification (OOS) issues, through investigation; verify corrective and preventive action (CAPA) effectiveness; contribute to HSE leadership.
  • Support training and competency evidence (P10) and learning management system (LMS) administration where delegated.
  • Maintain safe systems of work and working environments, comply with corporate and legal HSE requirements, ensure necessary health and safety information, instruction, training and supervision are completed on time, and consult on occupational health and safety matters.
  • Identify and correct unsafe conditions or behaviors and promptly report incidents and non-conformances in accordance with policy.
  • Undertake duties in accordance with current company policies and procedures.

Desired Qualifications

  • A quality assurance background.

About the Company

Opella

Global OTC & VMS self-care manufacturer

Opella makes a wide range of over-the-counter medicines, vitamins, minerals, and supplements for global consumers, covering about 100 brands and an 11,000-strong workforce. It develops, manufactures, and markets non-prescription health products that people can buy ready-made in stores for common needs such as pain relief, digestion, and allergy relief. The company differentiates itself with a large global manufacturing footprint (13 sites and 4 science and innovation centers) and its B Corp certification, signaling accountability to social and environmental standards. Its goal is to simplify self-care and put health in people’s hands for half a billion consumers worldwide.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Neuilly-sur-Seine, France
Founded
2018

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