Quality Assurance Associate

3 days 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.

The Quality Associate-Incoming Receipt and Release and Authorised Person is responsible for the receipt and release of incoming materials, the review and sign off of batch records and release of finished product as Authorised Person. The role supports the Authorised Person Lead in ensuring PCI procedures are adhered to for the receipt, incoming materials, and finished product release for supply by PCI. All aspects of this role are performed in accordance with the Therapeutic Goods Administration Release for Supply of Medicines and technical Guidance on the interpretation of the PIC/S Guide to GMP.

Roles & Responsibilities:
- Disposition (release or reject) of finished products for supply, acting as delegate for the Authorised Person Lead in accordance with the company procedures.- Review and Sign off of Master manufacturing and packaging batch records, preparation, issuance and approval of labels.- The receipt, testing, review, inspection, quarantine and disposition (release or rejection) of incoming materials for use in production, in accordance with company procedures.- Ensure to have current knowledge of the suppliers, the supply chain and the associated risks involved for the products purchased or received- Periodic checking of status of starting materials, packaging materials and incoming goods until they have been released for production use or distribution- Preparation of SOPs and maintenance of management tools such as Excel spreadsheets.- Assist in Internal and External audits.- Support the close out of Deviations, CAPA, change control, non-conforming materials/products- Assist with maintenance of the Material code list, Approved supplier list.- Facilitate required information /metrics for the QSRT including tracking of SOPs approaching review date.- Document control - issuance of company controlled documents (e.g. SOPs/Forms/Templates/BPRs, Specifications)- Other duties as directed by the Quality Operations Manager.

Your Skills & Experience:
- Bachelor of Science, Pharmacy or related Discipline- Previous experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality Control or Quality Batch Release role- Proficient user of Microsoft Word and Excel- Experience in Quality Control /Material Management

LI-CV1

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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