Back to Job SearchROLE OVERVIEW
An exciting opportunity for a QC/QA and Manufacturing Investigations Writer and Approver to join a leading pharmaceutical company based in the area. This pivotal role offers the chance to play a key part in maintaining GMP compliance and ensuring the integrity of investigation processes within a dynamic industry environment. You will be at the forefront of authoring, reviewing, and approving GMP investigations related to quality deviations, out-of-specifications, and CAPAs, supporting ongoing quality assurance and manufacturing excellence.
This role is ideal for a motivated professional looking to leverage their GMP, QA, or QC experience in a collaborative, fast-paced setting, contributing to the delivery of high-quality pharmaceutical or biologics products.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the QC/QA and Manufacturing Investigations Writer and Approver will be varied however the key duties and responsibilities are as follows:
- Author comprehensive GMP investigations for OOS, LER, deviations, and atypical results in QC and manufacturing environments.
- Perform root cause analysis using audit trails, batch records, logbooks, calibration records, and trend data.
- Review and approve investigations written by peers and SMEs for technical accuracy, compliance, and clarity.
- Evaluate product impact and support risk-based lot disposition decisions.
- As the QC/QA and Manufacturing Investigations Writer and Approver, you will ensure timely investigation closure with robust root cause assessments and defensible product impact evaluations.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the QC/QA and Manufacturing Investigations Writer and Approver we are looking to identify the following on your profile and past history:
- A Degree or higher level in science or engineering.
- Proven industry experience in GMP QA or QC within pharmaceuticals, biologics, or sterile manufacturing.
- A working knowledge and practical experience with TrackWise and Veeva Vault.
WHAT’S IN IT FOR YOU?
By joining our client, you will be part of a leading company dedicated to quality and compliance within the life sciences. This role offers excellent career development opportunities, involvement in critical investigations, and the chance to impact product quality on a meaningful scale. You'll work alongside industry experts in a supportive and innovative environment, with competitive benefits and ongoing training support.
Key Words: GMP / QC / QA / OOS / LER / CAPA / root cause analysis / pharmaceutical / biologics / sterile manufacturing / TrackWise / Veeva Vault
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
