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.
The purpose of the Authorised Person Lead is to oversee the release of finished product batches by PCI Melbourne. This role will ensure that each production batch has been produced and controlled in accordance with PCI's GMP requirements and any other regulations relevant to the production, control and release of investigational medicinal products.
The Authorised Person Lead is responsible for:
Overseeing the overall management of the batch release process, to ensure day-to-day operational and compliance requirements are met, compliance to regulatory requirements, and local and Corporate PCI procedures.
Maintaining a robust batch release process with supporting standard operating procedures (SOPs). This includes review and approval of master batch record templates, finished product specifications, and Authorised Person training and qualification.
The effective training and management of the Authorised Persons (AP) and batch release team at PCI Melbourne, and batch release operations to ensure planned batches are released according to defined timelines.
Ensuring that each batch of finished product for Phase 2 Clinical Trials, or greater, are approved by an AP before being released for supply.
Ensuring that the release of finished product batches by the APs consistently meet PCI's GMP compliance requirements for the control and release of investigational medicinal products for human use.
Supporting the investigation of non-conformances and deviations, as required, including CAPA, and providing guidance from an Authorised Person perspective.
Overseeing the Quality process within the manufacturing process:
Checking the manufacture and testing of the batch in accordance with defined release procedures.
Reviewing and approving o executed batch records (eBRs) as well as supporting documents / attachments.
Participate in external regulatory inspections by the Australian Therapeutic Goods Administration (TGA), as well as client audits, as necessary.
Lead continuous improvement initiatives relevant to the batch release process and participate in other site continuous improvement activities.
Support the completion of other Quality Operations team responsibilities as required.
Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
The mandatory qualifications and experience for this position are: Bachelor of Science, Pharmacy or related discipline
Two years experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality Assurance Batch Release or Quality Control (QC) position
Excellent written and verbal skills with good attention to detail
Documented cGMP training
The behavioural competencies for this position are: 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
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.
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