AddressLife 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.
The primary responsibilities of this position are:
- Managing and administrating the PCI PQS and e-PQS (MasterControl) in use at the PCI Melbourne site.
- Provide quality oversight and support of other GMP software systems as required (i.e. BlueMoutantain)
- Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, and lead time.
- Providing direction and expertise to employees to ensure the development, management, and implementation of departmental SOPs, ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
- Participating in PCI Centres of Excellence with the goal of harmonising quality systems across all PCI sites as part of the company's One PCI policy.
- Implementing new or enhanced PCI Corporate quality systems at the Melbourne site.
- Collaborate with other PCI stakeholders including Project Management, Warehouse, Human Resources, Production etc where required
- Managing the Change Management process and approving change controls.
- Manage and report metrics related to the Quality Systems and assist with the preparation of the Quality Management Review
- Support other compliance team responsibilities as required (e.g., Supplier Management and Customer Complaints etc)
- Ensuring 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 Compliance Lead
- Assisting with metrics, deviations, CAPA, non conforming materials/product investigations, complaints, and recalls as required.
- Other activities as directed by the Quality Compliance Lead or Quality Compliance Manager
Mandatory qualifications & experience:
- Bachelor of Science, Pharmacy or related discipline.
- Five years experience in cGMP pharmaceutical manufacturing and/or development, ideally in Quality Assurance.
- Excellent written and verbal skills with good attention to detail.
- Establishment and maintenance of Quality Management Systems in pharmaceutical companies.
- Management of internal and external audit schedules.
- Experience in customer and regulatory authority audits.
- Experience in the administration / use of MasterControl
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 Leader and team player
- Objective and robust decision maker
- Self-confident and self-respectful
- Excellent interpersonal, written and verbal communication
- Self-motivated, achievement and outcomes orientated
- Trusting and trustworthy
- Conscientious and diligent
- Positively embraces and is responsive to change
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
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.
