Company Profile
Our client is a well-established pharmaceutical manufacturer specialising in generic medicines, supplying regulated markets across Europe and North America. The site focuses on Oral Solid Dose (OSD) manufacturing, supported by modern facilities, strong GMP quality systems, and a culture of continuous improvement.
Job Summary
The QC Analyst will support the initiation, writing, review, and execution of laboratory investigations within a GMP QC environment. The role will focus on investigating analytical deviations, invalid results, and Laboratory Investigation Reports (LIRs) while applying structured root cause analysis and ensuring documentation meets regulatory and quality standards.
Key Responsibilities
- Initiate and write Invalids and Laboratory Investigation Reports (LIRs).
- Support the review and approval of laboratory investigation documentation in line with GMP requirements.
- Perform root cause analysis using tools such as Fishbone diagrams and 5 Whys.
- Support analytical testing using HPLC, GC, autotitrators, and wet chemistry techniques where required.
- Work cross-functionally with QC, QA, and Manufacturing teams to gather investigation data.
- Ensure investigations and documentation are completed accurately and within required timelines.
- Utilise TrackWise or similar electronic quality systems to manage investigations and deviations.
- Use LIMS to review laboratory data and support investigation activities.
- Contribute to continuous improvement initiatives within the QC laboratory.
Candidate Requirements
- 1-2years’ experience in a QC laboratory or similar GMP-regulated environment.
- Good working knowledge of HPLC, GC, autotitrators, and wet chemistry techniques.
- Experience initiating and writing Invalids and Laboratory Investigation Reports (LIRs).
- Previous experience working with LIMS.
- Experience using TrackWise or a similar electronic quality system.
- Strong planning, organisational, and problem-solving skills.
- Excellent communication and interpersonal skills.
- Microbiological experience would be a strong advantage.