Label Compliance Associate

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 overall purpose of the Label Compliance Associate is to ensure that all Clinical Trial labels generated at PCI are in compliance with the applicable label text approved by PCI and Client, and for ensuring that the printing of labels is in accord with applicable GMP requirements and PCI SOPs.

The Label Compliance Associate will facilitate all steps leading to label text approval, including obtaining PCI and Client approval, and ensuring that the label text meets TGA and/or applicable country regulatory requirements.

Role & Responsibilities:

- 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 staff and Client to facilitate the preparation of draft/final label text, including quantities of labels to be printed
- Ensure that the label text meets TGA and/or applicable country regulatory requirements
- Incorporating variable text information e.g. Batch number, Product Code, Kit Number (as applicable), Retest Date
- Manage kit lists in accord with applicable SOP(s)
- 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
- Seek Quality approval of printed labels prior to providing the labels to production
- Provide printed labels to production in a timely manner, supported by the applicable records/forms, in appropriate sealed packaging
- Ensure that appropriate stocks of base (unprinted) labels are held, and that the stocks are appropriately labelled with the applicable PM code
- Ensure that appropriate stocks of consumables are held (e.g. label printing ribbons)
- 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
- Destroy any labels that are damaged/not required during the printing process
- Evaluate options for additional/replacement hardware as applicable
- Follow company OHS requirements
- Implement continuous improvement actions as may be appropriate (e.g. updating SOP(s) and Form(s) applicable to label generation activities)
- Participate in Internal audits and Client audits as required
- Liaise with external printers to coordinate printing of labels (as may be applicable)
- Consult applicable global regulatory guidance as may be required, in the context of country specific label requirements for IMPs

Your skills and experience:

- Bachelor of Science, Pharmacy or related Discipline
- Excellent written and verbal skills with strong attention to detail
- Previous industry experience
- 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, 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

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._