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).

Primary Responsibilities:

- Lead the design and development of the Qualification and Validation program compliant to PIC/s and quality risk management principals
- Write, review and approve (as required) qualification/validation procedures, master plans, forms, templates, protocols and reports
- Lead the execution, monitoring and maintenance of the validation schedule to ensure schedule adherence and required escalations
- Support and executes qualification/validations of (including but not limited to) facilities, utilities, equipment and software
- Provide quality oversight of the asset system (i.e. Blue Mountain) and reviews and approves completed calibration/ maintenance records
- Support improvements/upgrades of other GMP software systems as required
- Provide training to new and existing employees in Validation
- Review and approve protocols and reports supplied by Third Parties providing validation services to confirm suitability and compliance to internal procedures
- Write and reviews qualification/validation deviations to determine root cause and potential impact to the qualification/validation
- Approves the release of the validation activities to the next stage of the qualification/validation
- Lead and writes periodic evaluations, and determines requirements for requalification/revalidation
- Lead and executes the design, execution and monitoring of decommissioning activities, process validation and cleaning validation activities, including needs assessments
- Support the assessment of test method validation (as required)




- Review and approve change controls pertaining to potential recommissioning and/or qualification/validation activities for recent, current or transferred equipment and processes
- 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.
- 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.
- Collaborate with other PCI stakeholders including Project Management, Warehouse, Human Resources, Production etc where required
- Reports metrics related to Validation and assist with the preparation of the Quality Management Review
- 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)
- Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
- Escalate quality issues to the Quality Compliance and Systems Manager as required
- Other duties as required by Manager

Qualifications & Experience:

- Bachelor of Science, Pharmacy or related Discipline
- Five years experience in cGMP pharmaceutical manufacturing facility, ideally in a Validation role
- Proficient user of Microsoft Word and Excel
- Experience in Validation and life cycle management
- Experience in using a e-Quality Management System in a pharmaceutical company
- Experience in customer and regulatory authority audits.
- Communication and responsiveness at all times
- Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
- Analytical thinker and solution finder/problem solver
- Collaborative, team player
- Objective and robust decision maker
- Self-motivated and achievement orientated
- Trusting and trustworthy
- Conscientious and diligent
- Positive, embraces and responsive to change

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📌 Senior Quality Associate (Melbourne)
🏢 PCI Pharma Services
📍 Melbourne