Company Profile:

Our client is a well-respected pharmaceutical manufacturer specializing in generic medicines, supplying regulated markets is seeking a Senior QC Analyst for a 12 month contract. The site focuses on manufacturing, supported by modern facilities, strong GMP quality systems, and a culture of continuous improvement.

Job Summary:

The Senior 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.
Utilize 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.

Requirements:

3–4 years’ 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.
Demonstrated use of root cause analysis tools such as Fishbone diagrams or 5 Whys.
Strong planning, organizational, and problem-solving skills.
Excellent communication and interpersonal skills.
Microbiological experience would be a strong advantage.

#LI-PC2