
Posted 24 days ago
Technical Operations Associate
PCI Pharma ServicesTechnical Operations Associate
Requirements
Pharmaceutical manufacturing or packaging experience, Bachelor of Science, Pharmaceutical, or Engineering degree, Knowledge of PIC/s GMP, Knowledge of PIC/s Quality Management System, Proficiency in ERP and MS Office
Skills
GMPERPMicrosoft Office
About the role
Responsibilities
- Verify ERP generated reports against production activity stock issuance and accountability through reconciliation
- Perform In-Process Control (IPC) checks to ensure correct procedures and documentation follow a right-first-time approach
- Act as an independent approval signatory for production actions in line with company procedures
- Drive Continuous Improvement (CI) projects, including the introduction of new processes and equipment
- Conduct on-the-job training and assessments for updated or new processes and equipment
- Manage action items from CAPAs and Change Controls effectively and in a timely manner
- Participate in risk assessments for equipment, processes, and safety
- Update Master Batch Records (MBR) templates and generate quality documentation such as new procedures and work instructions
Requirements
- Experience in pharmaceutical manufacturing and/or packaging
- Bachelor of Science, Pharmaceutical, or Engineering degree (or equivalent qualification)
- Working knowledge of PIC/s Good Manufacturing Practices (GMP)
- Working knowledge of PIC/s Quality Management System, specifically change management
- Proficiency in ERP systems and MS Office suite (Word, Excel, etc.)
- Strong organizational skills with the ability to manage competing priorities
- Excellent English written and verbal communication skills with high attention to detail
About the Company
PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.
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PCI Pharma Services · Moorabbin
