Quality Regulatory Documentation OfficerViatris envisions health not just as it is, but as it should be.
We act with courage and our unique positioning provides stability in a world where health needs are constantly evolving.
Viatris enables everyone worldwide to live healthier at every stage of life through three major pillars:Access: By providing high-quality, recognized medicines, regardless of the patient's location or situation.Leadership: By fostering sustainable growth and developing innovative solutions to improve patient health.Partnership: By leveraging our collective expertise to give everyone access to our products and services.Currently, our Quality Systems team is seeking a Documentation Officer/Regulatory Quality Compliance Officer to join the team.
The purpose of this role is to maintain document control for GxP documents, including actioning change requests, supporting and coordinating site projects involving changes to processes, products, equipment, systems, or facilities; ensuring GMP compliance.$2,000 new starter stay bonus to successful candidates!
(half paid at 6 months and the remainder paid when you reach one year with us).If you are a current science graduate, we encourage you to apply!Key duties of the role include:Review, create, and support the issuance of Master documents to ensure compliance with GxP, regulatory, and quality requirements.Manage, progress, and submit projects through to closure in accordance with departmental and business goals.Provide insight and apply creativity to challenging situations.Maintain current and comprehensive change management records.Ensure compliance with local/national regulations, cGMP, and applicable current compendia.Document, coordinate, and provide quality oversight for projects and change management ensuring appropriate action plans are in place to maintain regulatory and quality compliance.Support and encourage continuous improvement initiatives for the benefit of the Quality department and the wider business.Ensure activities comply with GxP, legal, and ethical standards.Plan, monitor, and achieve goals within set time frames.Provide, build, and maintain consistent, reliable, and accurate customer service.Present a professional image.Perform other duties as required by management.Communicate and endorse safety practices, monitor key safety performance indicators, and visibly participate in promoting safety policies and initiatives.To be considered for this role, applicants should have:Qualifications in Science or related field;High aptitude for Microsoft Word and Excel Programs;Strong Good Documentation practices;Attention to detail;Excellent communication and organization skills;Ability to establish and maintain relationships with peers, business contacts, and corporate management;Ability to effectively manage time and meet deadlines and targets with competing and conflicting priorities under minimal supervision;Ability to follow prescribed and detailed procedures to comply with GxP;Previous experience working within an Electronic Document Management System is desirable;Previous regulatory experience is desirable but not mandatory;Previous experience in a GMP Environment is desirable.Viatris Benefits:Employee rewards and discount platformAnnual wellness allowanceRecognition programsState of the art canteen onsite with a variety of subsidized food optionsBenefits for health and financial wellnessCorporate deals with vendors including superannuation fund, health insurance, and othersViatris Product loyalty programFree annual flu vaccination2 days of paid volunteer leave per annumAdditional paid parental leaveCareer and development planning for continuous growth and learningRetirement savings plansAnnual leave loading, as well as paid additional bereavement leaveCultureViatris has been named in Forbes' World's Best Employers 2022 list.
We have now received this recognition in each of our first two years – and for 2022, we are ranked in the top 10% of the 800 global employers who made the ranking.Viatris strives to create a positive, productive work environment where integrity, dignity, and mutual respect for all is ingrained in each and every one of us.Together, we are building a highly inclusive organization where employees are welcome to bring their best, authentic selves to work every day.Our goal is to provide a safe, supportive community where employees feel they belong and can use their unique experiences, perspectives, and skills to make a difference in the lives of others.At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can leverage your experience, perspectives, and skills to help make a positive impact on the lives of others.#J-18808-Ljbffr