Quality Assurance Specialist

The Quality Assurance Specialist is responsible for independently providing commercial quality support in the ANZ affiliate and plays an integral role as part of our crossfunctional teams. This role ensures all product process and system related quality activities within the affiliate from receipt of final product through to distributions are in compliance with Corporate Governmental and local regulations and requirements. 

KEY DUTIES AND RESPONSIBILITIES

• Support the integration of local quality regulations for biologics device and/or combination products and cosmetics.
• Maintain effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
• Perform local Product Release and Redressing activities for distribution for the local market 
• Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments
• Work on assessments to determine compliance to processes procedures and regulations to identify potential gaps and mitigate and implement improvements.
• Plan prepare review and approve quality documentation such as change controls product reviews and other local requirements.
• Support internal external and MoH audits as directed by the manager
• Coordinate and investigate quality events such as deviations nonconformances and corresponding action plans including decisions.
• Support supplier qualification program including performance monitoring for key suppliers.
• Monitor metrics and KPIs to ensure compliance.
• Represent Commercial Quality in cross functional teams projects and programs as assigned by management.
• Comply with all relevant company Occupational Health Safety and Environmental policies procedures and work practices with the intent of preventing or minimizing accidental exposures to self colleagues and/or the environment.
• Report any adverse event within 24 hours as per Allergans policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to Allergans / AbbVies internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties as requested.

Qualifications :

• Bachelors degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/scientific areas
• Experience in quality assurance GMP or GDP environment with familiarity with SAP TrackWise ComplianceWire and OneVault highly desirable 
• Full understanding of local GxP requirements including regulations and standards affecting device biologics pharmaceutical products and cosmetics with an indepth knowledge in one or more areas 
• General knowledge and understanding of AbbVie MD pharmaceutical biologic and cosmetic products and regulations.
• Excellent written and verbal communication and interpersonal skills with the ability to build relationships with stakeholders at all levels. 
• Ability to support projects as a team member or lead as assigned by manager.
• Excellent organisational and time management skills
• Make decisions in collaboration with management.
• Highly detailoriented proactive and able to work effectively in a team environment

Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information :

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

• AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers. 
• AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws. 
• All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law.  Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal. 
• AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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