20 Oct

Aps Application Review Officer Assessor Jobs Vacancy in Pca People Canberra

Aps Application Review Officer Assessor
Pca People
Canberra ACT
20 Oct, 2017 28 days ago

Pca People Canberra urgently required following position for Aps Application Review Officer Assessor. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Aps Application Review Officer Assessor Jobs Vacancy in Pca People Canberra Jobs Details:

The Licensing and Certification Section has responsibility for application management, inspection coordination, evidence assessment and administrative support functions. These include application review, scheduling of on-site inspections, desk top based compliance verification assessments, issuing licences, certificates and clearances, arranging overseas and domestic travel for inspectors, managing cost recovery functions and liaising with overseas regulatory agencies on the inspection of manufacturers. Key responsibilities include:

Working under limited direction in:
Receipting and reviewing licensing and certification applications, variation applications, and assisting in the determination of the appropriate inspection approach, required skill set and duration for inspections.

Managing group email inboxes by triaging all enquiries, assisting in providing responses to enquiries in relation to clearance, licence and certification enquiries; and providing support to the general enquiry phone line.

Undertaking decision making in accordance with defined parameters and applying professional judgement in assessing documentary evidence associated with clearance applications and related inquiries consistent with applicable regulatory requirements and principles of best practice regulation;

Assisting in the desk top based compliance verification/technical reviews of manufacturers.

Assisting in the scheduling of onsite inspections (both domestic and overseas) including assisting in the monitoring and prioritisation for scheduling inspections.

Assisting in the statistical analysis and providing details on the number, type, and kinds of applications received/processed and inspections performed assuming responsibility for own quality outcomes.

Assisting in the identification and implementation of process improvements, including drafting procedures and guidance document, when required, and assisting with managing risks in relation to these activities.

Initiating, establishing and maintaining strong relationships with a broad range of stakeholders , including liaising with inspectors, manufacturers and Australian sponsors to respond to their needs and expectations.

Undertake supervision of staff where required, including providing feedback, managing performance and identifying staff training needs.

Undertake other duties as directed, commensurate to the classification level of the position.

Job specific capabilities

Knowledge and experience in the application of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, other legislative instruments and/or regulatory guidelines is desired.

Ability to work under limited direction and make independent decisions relating to their area of responsibility.

Well developed communication skills and an ability to develop and maintain relationships to respond to the needs and expectations of stakeholders.

Ability to provide feedback and manage staff performance (where supervising).

Ability to assist with business improvement initiatives.

Mandatory Qualifications/Eligibility

A tertiary qualification in chemistry, biochemistry, microbiology, biotechnology, pharmacy or engineering from an Australian tertiary institute or equivalent overseas qualification.

Applicants must be Australian citizens.

Highly Desirable

A thorough understanding of manufacturing terminology and use of applicable manufacturing and regulatory standards/guidelines to assess applications for licences, certificates and GMP clearances is highly desirable.

This role requires a Baseline Security Clearance or the ability to obtain one. Candidates should be aware that the security clearance process can take some time to complete. To assist in the timely completion of the security clearance process, it is highly desirable that potential candidates currently hold or have previously held a Commonwealth Government Security Classification or have maintained Australian Residency for the past 10 years.

If you wish to apply please send through your MS word resume including a cover letter by following the apply links on this web page. If you would like to know more information please call Andrea Killebrew on 02 6162 7311 quoting reference #67563. Long term opportunity Immediate Start Fyshwick location

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