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Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description This position is responsible for assisting the Quality Operations team with the timely review of documentation and sub functions relating to Clinical or Commercial packaging of pharmaceutical dosage forms in accordance with relevant schedules and agreed timelines working to both Client Specific and internal procedures. In addition, this role is flexible into additional role(s) within the Operational Quality team. Individuals must complete training and show the capability, competence, experience, and expertise in another Operational Quality related role. Responsibilities: Pre-approval of Clinical/Commercial packaging orders and associated documents Post-production review of Clinical/Commercial batch records Complete Quality review of Clinical/Commercial supporting documentation Resolution of client observations on batch records following post-production review Assist with archiving of Clinical/Commercial batch records Support external customer related discussions on explaining internal processes for onboarding/audit related activities Flex and perform other Operational Quality role(s) based on business need Perform other related additional duties as requested by the Quality Operations – Team Leader Education/Qualifications: Essential: A-level or equivalent in relevant subjects Essential: Experience in pharmaceutical GMP Desirable: Degree level or equivalent in relevant subjects Experience: Desirable: Solid understanding and proven experience with GxP pharmaceutical packaging activities Knowledge, Skills, Abilities: Essential: High degree of accuracy, concentration, verbal and written communication Essential: Cooperation with inter/intra department teams to overcome challenges and provide support to other colleagues Essential: Ability to prioritise own workload to deliver personal and team objectives within set timeframes About Thermo Fisher: Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.