Production Associate

3 weeks ago

Moorabbin, Australia PCI Pharma Services Full time

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 Production Associate is to assist in labelling and secondary packaging campaigns in accordance with the Batch Records, Company SOPs and OHS requirements. The Production Associate is also responsible for facility and equipment cleaning and maintenance as applicable. The role requires extensive hands on work and will work closely with other Production personnel, Storage and Distribution, Projects and QA staff to complete required production activities in a cGMP compliant manner.

Production Associates have primary responsibility for the day to day labelling and secondary packaging activities in the production facility as scheduled by the Production Manager.

Production Associates will be responsible for completing batch records concurrent with labelling and secondary packaging activities and ensuring all steps are completed.

Production Associates will undertake facility cleans and day to day equipment calibrations as required by the batch records and company SOPs and record these activities using the applicable document (e.g. within batch records or using the applicable Forms or Registers).

Production Associates are responsible for removal of any production waste/rubbish once production is completed and for preparing for line clearance. Production Associates may be requested to perform line clearance sign off.

Production Associates will provide practical training and guidance to Production Assistants.

Production Associates also assist in the maintenance 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).
- Completing company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs are updated or new SOPs issued that are applicable to production)
- 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
- Picking released stock and equipment for labelling of clinical supplies and secondary 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 Supervisor review;
- Ensuring that all deviations are reported to the Production 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;
- Ensure that calibrations of equipment are performed 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;

Assisting other departments as required.

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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