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Position Overview
The Production Associate facilitates all steps involved in label text approval and printing, and packaging and labelling activities including;
obtaining approvals and ensuring that the label text meets TGA and/or applicable country regulatory requirements
ensuring that the printing of labels is in accord with applicable GMP requirements and as per PCI SOPs
completing campaigns in accordance with Batch Records, PCI SOPs, Work Instructions etc. and maintains EHS requirements, and
cleaning and maintenance verification for facility and equipment.
Position Specifics
ensuring all required information for label drafting and label printing received from Project Manager are complied with and executed accordingly
ensuring label text for each project is compliant and ready to be approved by the client/sponsor.
performing day-to-day packaging and labelling activities in the production facility as scheduled by the Production Associate Manager.
completing batch records accurately and concurrent with packaging and labelling activities and ensuring all steps listed are completed.
preparing for line clearance, and removal of any production waste/rubbish once production is completed. Production Associates may be requested to perform line clearance sign off.
assisting in maintaining of the cGMP facility licence and may be required to assist in facility audits (e.g. PCI internal audits and audits conducted by Clients/Sponsors and Regulatory Authorities).
Undergoing practical training and be involved in procedural updates and provide input for process designs.
Other Position Activities
Completing company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs, Work Instructions etc. are updated or new SOPs, Work Instructions etc. are issued that are applicable to production)
Facilitate all steps leading to label text approval, including preparing the draft label text for review/approval by PCI and Client
Liaise with all appropriate PCI employees to facilitate the preparation of draft/final label text, including label design decisions
Ensure that the label text meets PIC/s (Annex-13) and TGA regulatory requirements and in collaboration with the client the applicable country regulatory requirement
Incorporating variable text information e.g. Batch number, Product Code, Kit Number (as applicable), Retest Date etc as per client requirement
Manage kit lists in accordance with applicable procedures or work instructions
Liaise with company (or client) approved third party translators as may be required
Ensure that the printing of labels is conducted in a GMP compliant manner, using the correct base label and ribbon combination, that printing is in accordance with applicable PCI SOP(s) and that the appropriate PCI Forms/Records are completed and retained in the designated locations
Confirm that the combination of base label and ribbon will deliver a printed label that is fit for purpose for the intended substrate (packaging material) and storage conditions, and for conducting the appropriate rub/smudge/scratch adherence test on labels prior to issuance
Ensure that the quality of the printed labels obtain Quality approval prior to the labels being issued to production
Provide printed labels to be ready for production in a timely manner, supported by the applicable records/forms
Ensure that label printing is undertaken in such a way that there is no risk of mix-up, ensuring line clearance is undertaken prior to commencing each printing episode
Deface any printed labels that are damaged/not required during the printing process
Reconcile unprinted labels (blank…