Radiopharmacy QC Specialist — GMP Lab, Hybrid Work

Novartis; Baarle-Hertog; On-site; EUR 44,000 - 82,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Job summary

Novartis seeks a QC Officer to join the quality control team for medicinal products at the Baarle Nassau site in the Netherlands, contributing to QC processes in a strict GMP environment.

You will serve as a subject matter expert in analytical processes, write investigations, risk assessments, and manage qualification activities for laboratory systems and equipment, including documentation and deviations.

Qualifications

• 1+ years of experience in radiopharmaceutical QC laboratory or equivalent in a strongly regulated environment.
• Excellent knowledge of good laboratory practices and cGMP.
• Analytical mind-set and eye for detail.
• Open to new technologies and continuous improvement behaviour.
• Open and clear collaboration and communication with third parties.
• Shows the appropriate sense of urgency around given tasks.
• Fluent English, written and spoken.

Responsibilities

• The accurate execution of the quality control as defined in the specification of the respective medicinal product, intermediate or raw material.
• Awareness for any uncommon or unexpected incident, condition or detail during these controls and immediate notification of such deviation to the Qualified Person.
• Execution of the routine quality control testing conform analytical procedures and methods.
• Sampling, review and documentation of environmental monitoring according to the environmental control program effective on site. Reviewing the data and perform trend analysis.
• Manage and maintains the progress on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team.
• Coordinate and manage deviation and out-of-specification/out-of-expectation (OOX) investigations to be initiated, assessed, and closed out in timely manner
• Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation.
• Communicate needs and opportunities for improvement of devices / software / methods conform GMP requirements and needs of customer.
• Ensuring the QC Laboratory is maintained in an orderly and clean state.
• Adherence to radiation and conventional regulations, and preventing oneself to a state that could expose her/him or colleagues to any hazardous situation.

Skills

Good laboratory practices

cGMP knowledge

Analytical mindset

Open to new technologies

Collaboration with third parties

Fluent English

Job description

Novartis seeks a QC Officer to join the quality control team for medicinal products at the Baarle Nassau site in the Netherlands, contributing to QC processes in a strict GMP environment.

You will serve as a subject matter expert in analytical processes, write investigations, risk assessments, and manage qualification activities for laboratory systems and equipment, including documentation and deviations.