Quality Operations - Associate

Thermo Fisher Scientific; Horsham; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Operations Associate in Horsham. This role involves assisting the Quality Operations team with documentation review and ensuring compliance with GMP standards. Ideal candidates should possess relevant qualifications and strong communication skills.

Qualifications

• Essential: A-level or equivalent in relevant subjects.
• Essential: Experience in pharmaceutical GMP.
• Desirable: Degree level or equivalent in relevant subjects.

Responsibilities

• Pre-approval of Clinical/Commercial packaging orders.
• Post-production review of Clinical/Commercial batch records.
• Resolution of client observations on batch records.

Skills

High degree of accuracy

Communication

Team cooperation

Ability to prioritize workload

Education

A-level or equivalent in relevant subjects

Degree level or equivalent in relevant subjects

Job description

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Quality Operations – Associate

At Thermo Fisher Scientific team, you’ll 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
  
  

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Product Management, and Engineering

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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