Quality Operations - Associate

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.