Quality Operations Specialist

Novartis is hiring a Quality Operations Specialist. Level rates it ; you can apply on Novartis.

Level's read on this job

Little AI ●○○○ is how Level rates this role: aI is not part of the work.
Novartis has 856 other open roles on Level.
Posted in the last few days.

AI in this role

Job Description Summary

We are looking for Quality Operations Specialist - Temporary (6 Months)

Job Description

Major Accountabilities

Perform Batch Record Review and support timely and GMP-compliant batch release activities.
Ensure compliant documentation lifecycle management, including review, approval, archiving, and control of paper-based and electronic records.
Prepare, review and approve quality-related documentation, including operational procedures, protocols, work instructions, and controlled documents.
Support deviation and complaint investigations, including impact assessments, investigation follow-up, and timely closure.
Support CAPA, actions, change control, internal audit, and Health Authority inspection readiness activities, ensuring timely execution of defined actions.
Perform batch-wise Audit Trail Reviews in accordance with the approved plan and applicable procedures.
Perform routine QA walkthroughs and provide QA support to maintain GMP compliance within manufacturing areas.
Collaborate with Manufacturing, QC, Microbiology, Warehouse, and other cross-functional teams to ensure timely identification, escalation, and resolution of Quality and GMP-related issues.

Obligatory Requirements

Bachelor’s degree, preferably in Pharmacy, Chemistry, Chemical Engineering, Biology, Bioengineering, Life Sciences, or a related field.
Good knowledge of GMP and pharmaceutical Quality Systems.
Basic knowledge of applicable regulatory requirements.
Strong quality mindset and awareness of GMP requirements.
Excellent organizational skills with strong attention to detail.
Ability to work effectively in a team and communicate clearly with cross-functional stakeholders.
Demonstrates an appropriate sense of urgency and the ability to prioritize tasks in a dynamic operational environment.
Good command of English, both written and spoken.

Desirable Requirements

Previous experience or internship in Quality Assurance, Quality Control, or pharmaceutical manufacturing.
Experience or familiarity with Batch Record Review, deviation management, batch release, or shopfloor QA activities.
Familiarity with electronic manufacturing and Quality systems, preferably MES.
Experience in a GMP-regulated pharmaceutical manufacturing environment is an advantage.

Skills Desired

Collaboration, Communication, Data Integrity, Digital Fluency, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)

How we rate this

Quality Operations Specialist at Novartis rates 38 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.