QC Analyst – Cleaning Verification & Validation (Helsingborg)

WeQuel; Helsingborgs kommun; Sur place; SEK 334 800 - 446 400; Plein temps

Résumé du poste

A leading health sciences company is seeking a QC Analyst in Helsingborg, Sweden. The successful candidate will be involved in cleaning verification and validation, executing analytical testing using HPLC and GC, and ensuring compliance with GMP standards. This role requires proven experience in a GMP-regulated environment along with the ability to work independently and communicate effectively in English. Candidates with familiarity in pharmaceuticals or related fields are preferred.

Qualifications

• Proven experience working as a QC Analyst in a GMP-regulated environment.
• Hands-on experience with cleaning verification and/or cleaning validation.
• Strong practical experience with HPLC and GC.
• Solid understanding of GMP, documentation practices, and data integrity principles.
• Ability to work independently, in a structured and detail-oriented manner.
• Fluent in English, both written and spoken.

Responsabilités

• Perform cleaning verification and validation according to approved methods and protocols.
• Execute analytical testing using HPLC and GC techniques.
• Document and review results in compliance with GMP standards.

Connaissances

HPLC

GC

Cleaning verification

Cleaning validation

GMP compliance

Data integrity principles

Outils

LIMS

Description du poste

About the Role

As a QC Analyst, you will be responsible for both routine and project-based analytical activities related to cleaning verification and validation. You will play a key role in ensuring product quality and compliance, working closely with cross-functional teams within Quality, Manufacturing, and Validation.

Key Responsibilities

• Perform cleaning verification and cleaning validation in accordance with approved methods and protocols
• Execute analytical testing using HPLC and GC techniques
• Document and review results in compliance with GMP standards and data integrity requirements
• Investigate and troubleshoot analytical results and laboratory methods when necessary
• Ensure adherence to internal SOPs and regulatory requirementsContribute to continuous improvement of laboratory processes and documentation practices
• Collaborate cross-functionally with relevant stakeholders

Requirements (Must Have)

• Proven experience working as a QC Analyst in a GMP-regulated environment
• Hands‑on experience with cleaning verification and/or cleaning validation
• Strong practical experience with HPLC and GC
• Solid understanding of GMP, documentation practices, and data integrity principles
• Ability to work independently, in a structured and detail-oriented manner
• Fluent in English, both written and spoken

Preferred Qualifications

• Experience within pharmaceuticals, consumer health, or life sciences
• Previous experience working as a consultant
• Experience with method validation, method transfer, or troubleshooting
• Experience collaborating closely with Validation or Manufacturing teams
• Familiarity with LIMS or similar laboratory systems