Job Description
POSITION SUMMARY:
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We are looking for a
Quality Assurance Engineer to join our team on a
12 -month contract. The Quality Assurance Engineer is responsible for
n providing Quality Assurance oversight and support for commissioning,
n qualification, validation, technology transfer, process lifecycle management,
n capital projects, vendor qualification, and operational quality activities.
n This role is accountable for maintaining quality and compliance throughout the
n project lifecycle while supporting successful project execution and commercial
n operations. The incumbent is also responsible and
n accountable for the execution of the PSC mission, "to maintain the integrity
n and professionalism of our products and services while enabling steady growth
n and development".
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UTIES AND RESPONSIBILITIES:
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· Provide Quality Assurance oversight for
n engineering, validation, manufacturing, and capital project activities.
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· Review and approve GMP -related documents,
n including validation protocols, qualification documents, risk assessments,
n technical transfer documentation, and quality system records.
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· Support commissioning, qualification,
n validation, technology transfer, and process lifecycle activities to ensure
n compliance with regulatory and company requirements.
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· Facilitate and support quality systems
n including deviations, investigations, change controls, CAPA, and risk
n management activities.
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· Ensure compliance with cGMP, GxP, site
n procedures,



and applicable global regulatory requirements.
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· Provide quality guidance and risk -based
n decision -making to project teams and operational stakeholders.
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· Collaborate with Engineering, Manufacturing,
n Validation, Quality Control, Supply Chain, and Regulatory teams to achieve
n project and business objectives.
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· Participate in audits, inspections, and
n continuous improvement initiatives to maintain and enhance compliance and
n quality performance.
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· Support vendor qualification and supplier
n quality activities as required.
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· Additional duties and responsibilities may be
n assigned from time to time.
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DEMONSTRATED COMPETENCIES:
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Quality &
n Compliance Excellence – Strong
n understanding of cGMP, GxP principles, quality systems, validation lifecycle
n requirements, and global regulatory expectations.
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Relationship Building – Works with and across
n formal and informal professional and social networks to build long -term
n partnerships and connections in the life science industry.
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Problem solving –
n Identifies, researches, and demonstrates logical reasoning to communicate




n critical information.
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Rational Persuasion –, Active listening, Presents key factors influencing factors, and
n strategic goals to assist stakeholders in identifying solutions.
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Interpersonal Awareness – Ability to be aware of
n how actions, ideas, and communication can/does affect people and their
n outcomes.
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Agility – Meets objectives by responding to competing
n and changing priorities and multiple tasks under inflexible timelines.
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Requirementsn
REQUIRED EDUCATION AND WORK EXPERIENCE:
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Bachelor's Degree in Engineering
n or Life Science.
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Minimum 4 years
n of experience in Quality Assurance, Validation, , Manufacturing Quality, or
n Project Quality within the pharmaceutical, biotechnology, medical device, or
n other regulated industries.
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Demonstrated
n experience reviewing and approving GMP documentation including risk
n assessments, validation protocols, qualification documents, change controls,
n deviations, and CAPAs.
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Experience
n supporting technology transfer, process validation, qualification, engineering,
n manufacturing, or capital projects.
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Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and
n international regulatory requirements.
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Solid technical writing and document review skills.
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Ability to
n build and maintain relationships with stakeholders across multiple functions
n and organizational levels.
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📌 Quality Assurance Engineer (Melbourne)
🏢 PSC Biotech
📍 Melbourne