PCI Pharma Services in Moorabbin, VIC, AU.This Full time on site position offers excellent opportunities for career growth.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 ResponsibilitiesLead the design and development of the Qualification and Validation program compliant to PIC/s and quality risk management principalsWrite, review and approve (as required) qualification/validation procedures, master plans, forms, templates, protocols and reportsLead the execution, monitoring and maintenance of the validation schedule to ensure schedule adherence and required escalationsSupport and executes qualification/validations of (including but not limited to) facilities, utilities, equipment and softwareProvide quality oversight of the asset system (i.e. Blue Mountain) and reviews and approves completed calibration/ maintenance recordsSupport improvements/upgrades of other GMP software systems as requiredProvide 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 proceduresWrite and reviews qualification/validation deviations to determine root cause and potential impact to the qualification/validationApproves the release of the validation activities to the next stage of the qualification/validationLead and writes periodic evaluations, and determines requirements for requalification/revalidationLead and executes the design, execution and monitoring of decommissioning activities, process validation and cleaning validation activities,



including needs assessmentsSupport the assessment of test method validation (as required)Qualification/Validation subject matter expert for risk assessmentsReview and approve change controls pertaining to potential recommissioning and/or qualification/validation activities for new, current or transferred equipment and processesProvides 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 requiredReports metrics related to Validation and assist with the preparation of the Quality Management ReviewSupport 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 requiredOther duties as required by ManagerQualifications & ExperienceBachelor of Science, Pharmacy or related DisciplineFive years experience in cGMP pharmaceutical manufacturing facility,



ideally in a Validation roleProficient user of Microsoft Word and ExcelExperience in Validation and life cycle managementExperience in using a e-Quality Management System in a pharmaceutical companyExperience in customer and regulatory authority audits.Behavioural CompetenciesCommunication and responsiveness at all timesPositive, 'can-do' attitude, embraces and 'lives' PCI's Vision and ValuesAnalytical thinker and solution finder/problem solverCollaborative, team playerObjective and robust decision makerExcellent interpersonal, written and verbal communicationSelf-motivated and achievement orientatedTrusting and trustworthyConscientious and diligentPositive, embraces and responsive to changeJoin us and be part of building the bridge between life changing therapies and patients.Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.
We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
#J-*****-Ljbffr

📌 Senior Quality Associate (Validation) At Pci Pharma Services (Victoria)
🏢 PCI Pharma Services
📍 Victoria