The posting
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
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 labels) and printed labels that are to be used or rejected at the end of the print run.
- Evaluate options for additional/replacement hardware as applicable
- Liaise with external printers to coordinate printing of labels (as may be applicable)
- Ensuring the required Batch Record has been approved and QA issued prior to use
- Ensuring the required packaging room is ready for use and that appropriate Room logs and registers are completed
- Following the company gowning and hygiene requirements
- Verifying the picked released stock and equipment for labelling of clinical supplies and packaging and assembling kits of finished products in accordance with the Batch Records.
- Ensuring that samples are taken in accordance with the batch record instructions (e.g. retention samples).
- Reviewing production batch records and ensuring that these are completed and signed prior to Production Senior Associate review.
- Ensuring that all deviations are reported to the Production Senior Associate or Production Associate Manager.
- Making sure that production facilities are clean and when appropriate, disinfected.
- Cleaning of equipment in accordance with SOPs.
- Removing waste materials and rubbish from the packaging facilities and placing in the correct bins.
- Verify calibrations of equipment prior to use and records kept/registers completed.
- Ensuring that the premises and equipment are maintained and relevant records kept.
- Reviewing labels and randomisation lists against label approval forms and master randomisation lists prior to commencing batch manufacture.
- Preparing, reviewing and maintaining SOPs relevant to the Production facility.
- Participating in PCI internal audits and third-party audits and assist in responding to audit findings and product complaints/recalls as may be required.
- Follow company EHS requirements
- Implement continuous improvement actions as may be appropriate (e.g. updating SOP(s), Work Instructions and Form(s) applicable to label generation activities and processes)
- Completion additional tasks as allocated by the Senior Production Associates or Production Associate Manager
- Assisting other departments as required.
The role works closely with other Production, Warehouse, Project Management and Quality employees to complete the activities in a cGMP compliant manner
Qualifications, Experience & Behavioral Requirements:
- Previous industry experience in Pharmaceuticals and/or GMP environment
- Bachelor of Science, Pharmacy or related Discipline
- Excellent English written and verbal skills with good attention to detail
- Scientific experience
- Previous industry manufacturing/labelling 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
- Attention to detail
- Collaborative, team player
- Objective and robust decision maker
- Trusting and trustworthy
- Conscientious and diligent
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.
