Production Associate

6 months ago

Port Melbourne, 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.
- Key responsibilities & tasks of this position are:_
- Completing /leading company training requirements in accordance with curricula and other training as may be required (e.g. updates or new SOPs, equipment )
- Ensuring to comply with EHS requirements including raising formal notifications of non-compliance (e.g near miss, hazard identified, or continuous improvement)
- Verifying the required Batch Records have been approved and QA issued prior to use.
- Verifying production facilities and equipment's are clean prior to commencement of manufacturing activities via appropriate logs and registers.
- Ensuring to maintain a high level of personal hygiene as required in Pharmaceutical environment
- Adhering to the company’s Safety, Gowning and Hygiene requirements.
- Monitor operation requirement conditions and make adjustment as needed to comply with production requirements.
- Adhering to filling and filtering procedures while calculating dilutions, concentrations and yields
- Use ability to complete tasks in a complaint and safer manner
- Effectively communicate issues to Supervisors
- Assist in the identification and implementation of continuous improvement opportunities.
- Verify execution of batch records and log book documentation with details and accuracy.
- Verify and assist pharmaceutical production machinery and execute procedures for manufacturing such as dispensing, mixing coating, encapsulating, granulating, drying, milling, blending, compressing and the like.
- Identifies and assist in corrective actions of processing related issues
- Assist with the on the job training of other production trainees and operators.
- Ensure the in-process and QC/RS samples taken as per the MBR
- Assist the Supervisor by providing shop floor supervision, general production updates (e.g shift reports)
- Guide and lead production assistants in manufacturing and following procedures stated in the batch record
- Verify released or provisional released materials for manufacturing, setting up required equipment, ensuring all batch required equipment is calibrated, annotated within batch record, equipment register when and where applicable
- Identify, report and resolve issues with production with regards to equipment or formulation with consultation of Production, QA, Project Managers.
- Verifying bulk and finished products are in accordance with the Batch Records or alternative documentation
- Ensuring and verifying that samples are taken and recorded in accordance with SOPs, relevant Forms, batch record instructions (e.g. QC samples and retention samples)
- Verify the relevant inventories specified in the MBR
- Reviewing all production batch records and ensuring that these are completed and signed by all participating individuals prior to Production Supervisor review
- Ensuring that all production deviations are reported to Production Supervisors / Production Managers
- Performing routine cleaning of facility and equipment in accordance with SOPs, relevant Forms, batch record instruction
- Ensuring production facilities are clean prior to commencement of manufacturing activities via appropriate logs and registers
- Activity maintaining a high level of general housekeeping (daily and or rostered) reporting of non-compliance
- Verify waste materials and rubbish from the production facility and placing in the correct bins, supporting recycling.
- When shift times allow, provide detailed and technical hand over to incoming shift (within applicable manufacturing areas)
- Ensure to provide detailed end of shift hand over to Production Associate, Shift Supervisor
- Ensure equipment has been cleaned in accordance with SOPs prior to commencement of manufacturing.
- Ensure calibration of equipment is performed, and records kept/registers updated
- Reviewing, verifying and complying to label approval forms, label content, and randomization lists prior to commencing batch manufacture
- Preparing, reviewing and maintaining SOPS relevant to the manufacturing facility
- Reviewing batch records, providing ongoing feedback to Production and Project Managers
- 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 directed when and were 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, ci

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