Quality Compliance - Quality Services Intern
About the role
Responsibilities
- Support the compilation, tracking, and follow up of quality and regulatory
performance metrics across External Manufacturing.
- Where applicable, assist with the compilation of Regulatory Restriction
Forms and support regulatory requests received for filing applications.
- Work with Virtual Plant Teams to support progression of change controls
and other quality system activities, including deviations, CAPAs, product quality complaints, documentation, audits, and inspections.
- Support the preparation of regulatory summaries for Annual Product
Quality Reports.
- Provide quality and regulatory support to Contract Manufacturing
Operations within a cross functional team, contributing to the management of CMOs and ensuring alignment with applicable GMP, corporate policies, and regulatory requirements.
- Support ongoing quality and regulatory projects, continuous improvement
initiatives, and Operational Excellence efforts.
- Assist with the progression of GMP and regulatory documents within the
Documentation Management System, including review, processing, and authorship of quality or regulatory related procedures.
- Support the review and approval of site procedures and associated
documents as required.
- Engage in Quality Culture initiatives across External Manufacturing.
- Provide routine administrative support such as scheduling meetings,
preparing presentations, issuing meeting minutes, and maintaining action logs.
- Collaborate with relevant departments to support compliance and ensure
effective communication across teams.
- Perform other ad hoc tasks as assigned by management or relevant
quality representatives in support of team and departmental goals.
Qualifications, Knowledge and Skills Required
- Currently undertaking an undergraduate degree in a relevant scientific
discipline such as General Science, Biomedical Sciences, Biotechnology, Analytical Science, Pharmaceutical and Biomedical Chemistry, or Pharmaceutical and Industrial Chemistry.
- Strong time management and organisational skills, with the ability to
manage multiple tasks and work independently using initiative.
- Effective interpersonal, communication, presentation, and teamwork skills.
- Proficiency in key computer applications including Word, Excel, Access
and PowerPoint, with the ability to collect, analyse, interpret and present information clearly.
- Demonstrated ability to work in a fast-paced environment, balancing
several projects at once.
- Flexible, motivated, energetic and collaborative, with the ability to meet
targets and milestones.
- Confident public speaking skills and the ability to engage effectively with
others.
- Passion for the pharmaceutical sector and innovation in healthcare.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
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