Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirements, please feel comfortable to let our team know by emailing CareersANZ@abbvie.com or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.Job DescriptionThe Quality Assurance Specialist is responsible for independently providing commercial quality support in the ANZ affiliate and plays an integral role as part of our cross-functional 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 RESPONSIBILITIESSupport the integration of local quality regulations for drugs, 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, non-conformances 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 Allergan’s policies and procedures.Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.Adhere to Allergan’s / AbbVie’s internal codes of conduct and compliance processes.Other ad hoc duties such as administrative duties, as requested.QualificationsBachelor’s 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 in-depth 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 detail-oriented, proactive, and able to work effectively in a team environment.Flexibility and AvailabilityIn line with Australia’s '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 InformationWAYS WE WORKAll 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 doesn’t 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. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENTAbbVie 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 Company’s 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 AbbVie’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html
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