Radiopharma QC Specialist (GMP) – Hybrid

Novartis AG; Noord-Brabant; On-site; EUR 44,000 - 82,000; Full time

Job summary

Novartis Baarle Nassau, Netherlands, is seeking a QC Officer to contribute to quality control of medicinal products in a GMP environment. You will apply SOPs, execute analytical testing, and support investigations as SME.

Requirements include 1+ year radiopharmaceutical QC experience, fluent English, and strong collaboration with the Qualified Person and cross-functional teams. The role is onsite with no relocation support.

Qualifications

• 1+ years of experience in radiopharmaceutical QC laboratory or company 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.
• Coordination with AS&T in project management, validation, revalidation and/or technology transfer related to analytical equipment. 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

Quality control

Analytical mind-set

Open to new technologies

Communication with third parties

Fluent English

Job description

Novartis Baarle Nassau, Netherlands, is seeking a QC Officer to contribute to quality control of medicinal products in a GMP environment. You will apply SOPs, execute analytical testing, and support investigations as SME.

Requirements include 1+ year radiopharmaceutical QC experience, fluent English, and strong collaboration with the Qualified Person and cross-functional teams. The role is onsite with no relocation support.