QA Technical Specialist

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    23 hours ago
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An opportunity exists for a pro-active person to join the Manufacturing Quality team at the Hospira (a Pfizer company) Melbourne site in the role of Quality Assurance Technical Specialist. We are seeking a dynamic, goal orientated individual with a keen eye for detail who wishes to further their career in the pharmaceutical industry.

Reporting to the Manufacturing Quality Manager, your key responsibilities will include:

+ Resolution of quality related issues through investigations in order to support the timely release of finished product

+ Partner with QC Microbiology Laboratory and Production to provide assistance with, and monitor laboratory and aseptic operations, inspection and packing operations and compliance status

+ Act as Quality reviewer and approver for GxP documentation including procedures, validation documentation, deviations, CAPA related records, risk assessments and change controls

+ Undertake QA walkthroughs and internal inspections within the site departments, as required

+ Perform in accordance with company policies and regulatory requirements for Quality, HR, EHS

+ Provide compliance and technical support to other site departmental groups and Corporate, as required

+ Review, develop and support the introduction of systems, practices, cultural changes and continuous improvement initiatives that enable the department to meet business demands within agreed timeframes and expected GxP standards

+ To undertake the immediate and long term service delivery of defined aspects of the Quality Assurance stream, including participation in improvement plans to meet the Process Streams goals and Key Performance Target’s (KPT’s)

The successful candidate for the key role within our team will need to possess:

+ Bachelor of Science (Microbiology/Chemistry) or related discipline

+ Sound knowledge of computer packages e.g. Word, Excel

+ Minimum 5 years’ experience in quality assurance, pharmaceuticals and/or regulated environments

+ Demonstrated knowledge of TGA, FDA, EU GMP and other quality related systems. (E.g. ISO standards)

+ Planning and time management skills; ability to work independently with minimal supervision

+ Strong customer focus, problem solving, decision making and negotiation skills

+ Experience and knowledge in Investigations, CAPA management, laboratory and aseptic manufacturing

+ Excellent communication (written and verbal) skills

+ High level of attention to detail

Apply now!

**Internal Reference: #LI-PFE**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control