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.
Position Overview:
This position is based in the Quality Operations team, reporting to the Authorised Person Lead, and will be a supporting role in the creation, review and approval of Batch Release and Label documentation, including other documentation required to support product certification or Batch Release. This role will enable timely and accurate review/approvals of records and Labels to GMP Annex 13 and 16 requirements and support ‘Quality On the Floor’ for prompt issue resolution and quality oversight of GMP activities. This role will work closely with key stake holders (including but not limited to) Production, Quality, Project Managers, at PCI-MEL and within the PCI Network.
Primary Responsibilities include:
Review and approve new and executed manufacturing (Packaging and Labelling) batch records to ensure compliance with GMP, data integrity standards, the Product Specification File (PSF), and Finished Product Specification
Disposition inventory (material and product) and approve Bill of Materials (as required) prior to Production activities within electronic inventory management system
Review, approve and issue labels created in Prisym 360 within defined timelines to meet agreed production schedule dates
Create certificates of conformance, stability assessments, product specifications and Product Specification Files
Issue and archive documentation pertaining to Batch release and other Quality related documentation
Complete, review and support site investigations/escalations for the determination of root cause/impact/risk for EVENTs, Deviations, Complaints, Non-Conformance and change controls for records relating to Batch Release or Quality
Support the certification of finished product batches (performed by the Authorised Person/s) by the checking and verification of required documentation and retention samples for Release for Supply in line with defined procedures
Support the completion of internal, client and regulatory inspections, including the response to findings and completion of corrective and preventative
Complete audit trail reviews for GMP software system in accordance with site procedures
Create, prepare and review/approve Quality and operational SOPs/WI/Forms (as required)
Support mock recall and recall activities instigated by PCI or clients
Point of contact for Production escalations requiring Quality assessment/escalation. Where required, support the assessment of packaged/labelled product quality during Production activities.
Report metrics related to Batch Release and assist with the preparation of Quality Management Review information
Support the completion of other Quality Operations team responsibilities as required (e.g., Product/Material Inspections, Retention sample collection 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 Authorised Person and Quality Operations Manager
Qualifications and Experience:
Bachelor of Science, Pharmacy or related Discipline
Experience in cGMP pharmaceutical/clinical trial environment
Proficient user of Microsoft Word and Excel
Experience in a Quality role within a pharmaceutical/clinical trial company
Use of quality management system and inventory management system software in a regulated industry
Behavioural Competencies:
Compliance and adherence to PCI procedures and policies
Attention to detail
Ability to work in fast-paced environment
Communication and responsiveness at all the times
Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
Analytical thinker and solution finder/problem solver
Collaborative, team player
Excellent interpersonal, written and verbal communication
Trusting and trustworthy
Conscientious and diligent
Positive, embraces and responsive to change
Flexible with managing workload in line with business priorities
Effective time management
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.
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.