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Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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Job Information

Oracle Quality and Compliance Consultant ASIA/PACIFC in Australia

Job Description

A Regulatory Compliance Consultant supports Oracle Life Sciences Global ISO certifications; as well as: Adherence to pharmacovigilance (adverse event reporting), data privacy (state and federal level), industry (GCP, GEP, GPP and GVP), internal (vendor management and training), pharmaceutical clients, and other regulatory (FDA and HIPAA) requirements. This position will report to the Senior Global Quality and Compliance Manager.

Career Level - N/A

Responsibilities

  • Responsible for implementing established quality processes & ensuring adequate application among Asia/Pacific teams

  • Responsible for ensuring that all projects are conducted in accordance with Oracle Life Sciences SOPs

  • Perform internal and external auditing based on Oracle Life Science’s quality system standards; for example, ISO 9001:2015, ISO 20252:2019, PV, FDA readiness audits

  • Responsible for ensuring compliance with pharmacovigilance requirements

  • Communicate team, or domain level, goals that support and advance team, domain level, and/or organizational compliance objectives; monitor metrics, or other performance measures, to track progress against established goals

  • Influence diverse stakeholder groups and drive acceptance of policies, practices and procedures within broader area of responsibility

  • Identify, propose, and support team- and domain level, quality and process improvement initiatives; lead or influence strategic initiatives at the domain level and provide input on strategic initiatives for the organization

  • Assist with training, guidance and feedback to encourage success and promote associate growth through regular domain developmental conversations and identification of domain developmental opportunities

  • Maintain quality and compliance documentation- e.g. SOPs, templates, working instructions

  • Organize and deliver trainings from clients and/or industry guideline trainings internally to Associates and externally to our vendors

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