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Senior R&D QA Associate, Procedural Document Specialist

Senior R&D QA Associate, Procedural Document Specialist

Position Title: Senior R&D QA Associate, Procedural Document Specialist
Number of Vacancies: 1
Start Date: ASAP
End Date: 30/6/2024
Location: CSL Melbourne Elizabeth Street
Team Size: 1 person in Australia, plus a colleague in the US, 4 in the team in total, wider team of 13; will be in contact with people outside of AU.
Flexibility: Yes, some of the work can be done remotely, at least 2 days in the office required.
Hours: Mon to Fri, standard hours.
If the person works more than 38 hours in the week, are you prepared to pay penalty rates for overtime? Unlikely to require overtime.
Potential to Extend: Potentially yes, for the right candidate, depends on the timing of the project.
Reports To: Manager R&D Global Document Management Systems
Reporting Structure: Breadth within the organisation for which the employee is responsible, workflow involvement, no budgetary responsibility.
Minimum Education: University degree in a relevant business, communication, technology, science discipline, or equivalent education or experience.

Minimum Experience Requirements:
*Minimum of 1-year experience in use and administration of DMS.
*Pharmaceutical industry experience of at least 1 year in Quality or R&D environment.
*Knowledge of industry regulations, with an emphasis on GxP guidelines.
*General understanding of quality systems and appreciation of the need for regulatory compliance.


Job Description:
This position exists as a member of the Global R&D QA department assisting the R&D QA Quality Systems organisation with management of the Document Management Systems (DMS) activities to support the R&D Quality Management System. The Senior R&D QA Associate will be responsible for the overall content and maintenance of the DMS system on behalf R&D Quality and will coordinate document management workflow activities for personnel supported by the R&D Quality Systems organisation. Provides support for global R&D and QA organization in GXP compliance related matters, including assurance that all aspects of procedural document management comply with GXPs, legal, regulatory requirements, and CSL Quality Manual requirements.

Must-Haves:
* Excellent Microsoft Word skills, particularly in formatting
* Strong attention to detail
* Database experience
* Working in a regulated environment (R&D or manufacturing)

Candidates must have sufficient work rights to be able to work in the position for the duration of the contract and potentially longer, as the position may extend.

Role:
*Extensive work in the database – receive documents for routing, review documents, formatting of Word documents
*Routing documents for approval
*Receiving documents back and adding effective date
*Database cleanup as required

Principal Accountabilities:
1.Collaborate with Global R&D Functions (30%):
*Capture DMS needs of global R&D functions.
*Participate in DMS initiatives.
*Create consistency across the CSL R&D organization.
*Liaise with procedural document management contacts for best practices.

2.Manage Procedural Documents in DMS (35%):
*Provide SME advice on procedural document management.
*Publish and route approval of GxP procedural documents.
*Ensure compliant assignment of document properties.
*Facilitate document change control.
*Maintain procedural document templates.
*Monitor document effective dates and facilitate periodic reviews.
*Basic system troubleshooting.

3.Support Audits and Inspections (10%):
*Provide accessible records from the DMS for internal audits and regulatory inspections.

4.Quality KPI Metrics (15%):
*Provide Quality KPI metrics related to procedural document management.
*Follow up with document owners to ensure timely review and update.

5.Stay Current with Industry Trends (5%):
*Stay informed about industry trends.
*Contribute innovative ideas to enhance the overall DMS experience.

6.Support Management (5%):
*Support the Head, R&D Quality Systems/Manager, R&D Global Document Management Systems in day-to-day activities.

7.Other Duties (TBD):
*Perform other job duties as assigned from time to time.

Scope/Accountability: No direct reports. Global focus to support R&D and R&D QA function. Interaction with cross-functional R&D teams and other Global Quality functions (Site QA and Global Quality Systems). No budget responsibility.

Impact/Influence/Liaison:
*Influencer in ensuring project compliance with GxP and applicable regulations.
*Mentoring/teaching team members.
*Collaborates effectively with others and influences stakeholders towards global outcomes.
*Drives alignment across the organisation.

Key Relationships: Internal – Cross-functional. External – None
Decision Making: Under general supervision, provides support on Quality Systems to ensure compliance with company standards and GxP regulatory guidelines. Key competency for this role includes problem-solving, prioritisation, and providing solutions.

Innovation: Provides input into the development of global DMS processes, process improvements, and directly implements changes. Actively contributes to discussions on innovations and supports their implementation.

Knowledge, Skills & Competencies:
*Ability to interact, communicate, and work globally.
*Experience in coordinating training and learning programs.
*Attention to detail.
*Ability to work independently and as a team member.
*Planning and coordination.
*Written and oral communication skills.
*Proficiency in appropriate software.
*Strong customer focus.


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