Our client, a leading pharmaceutical organization, is seeking a professional to provide quality support for laboratory activities at a manufacturing site. The role ensures consistent compliance with quality standards, data integrity, and the timely release of test results through robust quality oversight.
Responsibilities
* Provide QA oversight of QC laboratory operations to ensure compliance with cGMP and regulatory requirements.
* Review and approve GMP documentation, including SOPs, work instructions, protocols, and validation reports.
* Ensure change controls, deviations, OOS/OOT events, and CAPAs are handled in a timely and compliant manner.
* Perform QA walk-throughs and check rounds in laboratory areas to ensure adherence to data integrity principles.
* Assess root cause analyses for laboratory investigations and ensure that corrective actions are appropriate and sustainable.
* Support optimization initiatives and small-scale improvement projects within the quality and laboratory teams.
* Promote a strong quality mindset and compliance culture across the organization through proactive stakeholder collaboration.
Requirements
* You have a Bachelor or Master degree in Chemistry, Pharmaceutical Sciences, Life Sciences, Bioengineering, or a related scientific discipline.
* You bring experience in Quality Assurance, Quality Control, or laboratory operations within a GMP-regulated environment.
* You possess experience with quality systems including deviation handling, change control, and CAPA.
* You have knowledge of cGMP standards and ICH guidelines.
* You bring a solid understanding of laboratory testing, documentation, and data integrity principles such as ALCOA+.
* You are a proactive professional with a solution-oriented mindset and strong analytical decision-making skills.
* You are fluent in English.
Nice to Haves
* Understanding of pharmaceutical qualification and validation processes.
* Experience with trending and identifying recurring issues within laboratory processes.
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