Quality Operations - Associate
Quality Operations - Associate
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Quality Operations Associate
At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture
dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Position Summary:
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 activitie
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
Required Experience:
IC
Employment Type
Full-Time
