Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Purpose:
Assist the Quality Assurance Manager in the overall development, maintenance, and continuous improvement of the Quality Management Systems at PCI Melbourne. Specifically, the compliance, management, training, implementation and updates of the PQS and e-PQS, and other GMP software systems requiring quality oversight (including but not limited to MasterControl and BlueMountain).
Maintain robust Quality monitoring (and the review of compliance to metrics) to ensure the assessment of an effective quality management system and the escalation of adverse trends.
Primary responsibilities:
- Oversee the overall management of the e-PQS (MasterControl), to ensure day-to-day operational and compliance requirements are met, compliance to regulatory requirements, and local and Corporate PCI procedures. This includes improvements/upgrades and local administrative functions.
- Provide quality oversight of site PCI PQS, and support improvements/upgrades of other GMP software systems as required (i.e. BlueMountain)
- Manage day-to-day review, approval and routing of GMP software system records (i.e. Mastercontrol, BlueMountain etc).
- Manage PQS training to new and existing employees, in the e-PQS (including but not limited to), deviations, customer complaints and CAPA
- Manage the review, approval and escalation of events, deviations and customer complaints.
- Support the completion of investigations to determine root cause and effective corrective and preventative actions to prevent recurrence
- Manage and drive continuous improvements to assist in enhancements in departmental operational performance, compliance to regulatory requirements, improvements in site Standard Operating Procedures (SOPs) and meeting external and internal customer requirements, with respect to quality, service, and lead time.
- Provide 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 Centre’s of Excellence as appropriate with the goal of harmonizing 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
- Oversee the site Change Management process, and review and approve change requests and change records
- Report metrics related to the Quality Management Systems and assist with the assessment of PQS effectiveness.
- Drive site improvements to address adverse trends and/or areas of improvement
- Support regulatory inspections and act as a subject matter expert in the PCI PQS and e-PQS
- Support the completion of other compliance team responsibilities as required (e.g., Supplier Management, Client Audits and Internal Audits etc)
- Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
- Escalation of quality issues to the Quality Assurance Manager
- Other activities as directed by the Quality Assurance Manager or Quality Director
- Carry out the following people management responsibilities for direct reports (employees, contractors, casuals etc.) and/or within the Team, in accordance with organisational policies and applicable laws:
- Interview, hire and onboard;
- Plan, assign/delegate, and direct business priorities and/or work;
- Coach, develop and/or train;
- Appraise and manage performance and outcomes;
- Recognise, reward and discipline; and
- Manage workplace issues and address complaints to resolve problems in a timely manner in the event of escalation
Qualifications & experience:
- Bachelor of Science, Pharmacy or related discipline.
- Ten years experience in cGMP pharmaceutical manufacturing and/or development, ideally in Quality Assurance.
- Proficient user of Microsoft Word and Excel
- Experience with e-PQS or other electronic document management systems
- Experience in maintenance of Quality Management Systems in pharmaceutical companies.
- Experience in customer and regulatory authority audits.
- Experience in performing an administer function in electronic software systems
Behavioural competencies required for this position:
- High level of professionalism, ethics, quality of work, 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
- Excellent interpersonal, written and verbal communication
- Self-motivated and achievement orientated
- Trusting and trustworthy
- Conscientious and diligent
- Positive, embraces and responsive to change
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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.
