Join to apply for the Quality Operations - Associate role at Thermo Fisher Scientific
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.
Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Work Schedule: Standard (Mon-Fri)
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.
Thermo Fisher Scientific is an equal opportunities employer.
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