Quality Associate- Authorised Person

at  PCI Pharma Services

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:
The purpose of the Quality Associate-Finished Product Release and Authorised Person is to support the Authorised Person Lead in ensuring PCI procedures are adhered to for the release of finished product release for supply for use in clinical trials.
All aspects of this role are performed in accordance with the Therapeutic Goods Administration (TGA) Release for Supply of Medicines and technical Guidance on the interpretation of the PIC/S Guide to GMP.

The primary responsibilities & tasks of this position are:

• Ensure that each batch of finished product for Phase 2 or greater Clinical Trials is released according to the requirements of an AP as outlined in PIC/S PE-009 Annex 16) before being “Released for Supply”.
• Ensure that batches are released in accordance with defined timelines.
• Ensure that the release of finished product batches consistently meets PCI’s GMP compliance requirements for the control and release of investigational medicinal products for human use.
• Review batch records and supporting documents for each batch of finished product for Phase 2 or greater Clinical Trials and perform the Release for Supply for clinical trial use as an Authorised Person.
• Contribute to ensuring a robust and compliant batch release process by creating and/or reviewing supporting procedures: Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Review and approval of master batch record templates.
• Support external regulatory inspections by the Australian Therapeutic Goods Administration (TGA), Internal Audits and Client Audits, as necessary.
• Support the close out of Deviations, CAPA, Management of Change records (MOCs), non-conforming materials/products (NONCs).
• Ensure the required information for monthly batch release right first time (RFT) metrics is collated, recorded and actioned appropriately.
• Review and approve finished product labels for production use.
• Assist with other activities to support Production e.g. Line Clearance, quality issues
• Support continuous improvement initiatives relevant to the batch release process and participate in other site continuous improvement activities
• Other duties as directed by the Quality Operations Manager.

The mandatory qualifications & experience:

• Bachelor of Science, Pharmacy or related Discipline
• Two years experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality role
• Proficient user of Microsoft Word and Excel

The desired qualifications & experience:

• Manufacturing experience

The behavioural competencies required for this position:

• 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

This position:

• Is based at the PCI Melbourne site in Moorabbin;
• Requires a motivated, level headed individual with the ability to encourage a positive attitude in team members;
• Fosters a culture of work life balance, well being and resilience; and
• Is predominately office based with some warehouse and manufacturing support activities.

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

• Ensure that each batch of finished product for Phase 2 or greater Clinical Trials is released according to the requirements of an AP as outlined in PIC/S PE-009 Annex 16) before being “Released for Supply”.
• Ensure that batches are released in accordance with defined timelines.
• Ensure that the release of finished product batches consistently meets PCI’s GMP compliance requirements for the control and release of investigational medicinal products for human use.
• Review batch records and supporting documents for each batch of finished product for Phase 2 or greater Clinical Trials and perform the Release for Supply for clinical trial use as an Authorised Person.
• Contribute to ensuring a robust and compliant batch release process by creating and/or reviewing supporting procedures: Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Review and approval of master batch record templates.
• Support external regulatory inspections by the Australian Therapeutic Goods Administration (TGA), Internal Audits and Client Audits, as necessary.
• Support the close out of Deviations, CAPA, Management of Change records (MOCs), non-conforming materials/products (NONCs).
• Ensure the required information for monthly batch release right first time (RFT) metrics is collated, recorded and actioned appropriately.
• Review and approve finished product labels for production use.
• Assist with other activities to support Production e.g. Line Clearance, quality issues
• Support continuous improvement initiatives relevant to the batch release process and participate in other site continuous improvement activities
• Other duties as directed by the Quality Operations Manager