Senior QC Investigator: OOS/OOT & CAPA Excellence

Recipharm; Stockholms kommun; On-site; SEK 1,092,000 - 1,142,000; Full time

Job summary

Recipharm is seeking an experienced QC Investigator to lead investigations of OOS, OOT, and other quality events within Quality Control. You will provide scientific leadership, assess product impact, and drive CAPAs in a GMP environment.

You will collaborate with QA, manufacturing, and development teams, review data and methods, and ensure timely, compliant investigations with robust documentation and risk-based decision making.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Master's degree preferred in a related field.
• Training in quality systems or problem-solving methodologies is a plus.

Responsibilities

• Lead and coordinate OOS/OOT and related investigations.
• Review analytical data, notebooks, and methods to ensure robust conclusions.
• Author and approve investigation reports with data-driven outcomes.
• Recommend CAPAs and support continuous improvement in GMP context.
• Ensure investigations meet timelines and regulatory expectations.

Skills

OOS/OOT investigations

Quality Control collaboration

Data interpretation

Regulatory support

LIMS & CDS knowledge

Education

Bachelor's in Chemistry/Biochem/Pharma/Biology

Master's in a scientific discipline

Quality Systems / RCA / Lean Six Sigma training

Tools

LIMS

Chromatography instruments

eQMS

Job description

Recipharm is seeking an experienced QC Investigator to lead investigations of OOS, OOT, and other quality events within Quality Control. You will provide scientific leadership, assess product impact, and drive CAPAs in a GMP environment.

You will collaborate with QA, manufacturing, and development teams, review data and methods, and ensure timely, compliant investigations with robust documentation and risk-based decision making.