Job Description
The Senior Quality Associate – (Validation) is accountable for leading and executing the development, implementation, execution and maintenance of a robust and compliant Validation Program which includes: Site Validation Master Plan (VMP), Cleaning VMP, Facilities, Utilities, Equipment and Software Qualification (IQ/OQ/PQ), and Process Validation (PV).
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Primary Responsibilities:
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Lead the design and development of the Qualification and Validation program compliant to PIC/s and quality risk management principals
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Write, review and approve (as required) qualification/validation procedures, master plans, forms, templates, protocols and reports
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Lead the execution, monitoring and maintenance of the validation schedule to ensure schedule adherence and required escalations
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Support and executes qualification/validations of (including but not limited to) facilities, utilities, equipment and software
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Provide quality oversight of the asset system (i.e. Blue Mountain) and reviews and approves completed calibration/ maintenance records
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Support improvements/upgrades of other GMP software systems as required
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Provide training to new and existing employees in Validation
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Review and approve protocols and reports supplied by Third Parties providing validation services to confirm suitability and compliance to internal procedures
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Write and reviews qualification/validation deviations to determine root cause and potential impact to the qualification/validation
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Approves the release of the validation activities to the next stage of the qualification/validation
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Lead and writes periodic evaluations, and determines requirements for requalification/revalidation
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Lead and executes the design, execution and monitoring of decommissioning activities, process validation and cleaning validation activities, including needs assessments
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Support the assessment of test method validation (as required)
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Review and approve change controls pertaining to potential recommissioning and/or qualification/validation activities for current, current or transferred equipment and processes
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Provides direction and expertise to employees to ensure the development and implementation of departmental SOPs that are compliant to regulatory requirements, and are 'fit for purpose' operationally and commercially.
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Participate in the PCI Centres of Excellence as appropriate with the goal of harmonising quality systems across all PCI sites as part of the company's One PCI policy.
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Collaborate with other PCI stakeholders including Project Management, Warehouse, Human Resources, Production etc where required
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Reports metrics related to Validation and assist with the preparation of the Quality Management Review
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Support the completion of other compliance team responsibilities as required (e.g., Supplier Management, CAPA completion, Deviation investigations and Customer Complaint investigations, Client audits, Internal audits, Regulatory audits etc)
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Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
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Escalate quality issues to the Quality Compliance and Systems Manager as required
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Other duties as required by Manager
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Qualifications & Experience:
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Bachelor of Science, Pharmacy or related Discipline
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Five years experience in cGMP pharmaceutical manufacturing facility, ideally in a Validation role
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Proficient user of Microsoft Word and Excel
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Experience in Validation and life cycle management
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Experience in using a e-Quality Management System in a pharmaceutical company
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Experience in customer and regulatory authority audits.
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Communication and responsiveness at all times
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Positive, 'can-do' attitude, embraces and 'lives' PCI's Vision and Values
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Analytical thinker and solution finder/problem solver
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Collaborative, team player
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Objective and robust decision maker
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Self-motivated and achievement orientated
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Trusting and trustworthy
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Conscientious and diligent
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Positive, embraces and responsive to change
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📌 Senior Quality Associate (Victoria)
🏢 PCI Pharma Services
📍 Victoria