Job Summary:
We are seeking a Senior Laboratory Quality Assurance Specialist to join our team. This is a fantastic opportunity to work in a state-of-the-art fill-finish facility and vaccine biologics plant.
Responsibilities:
* Movement of materials across the network.
* System transactions including movement and shipping of samples across QC labs within the network.
* Inspection of primary packaging
* Participate in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
* Where applicable, review, approve and trend test results.
* Peer review other analysts' documentation, ensuring QC Right First Time KPIs are achieved.
* Participate in QC daily meetings and ensure effective communication of testing progress, deviations etc.
* Ensure that all Quality Systems within the department are adhered to on a daily basis.
* Complete all documentation in compliance with GMP and GxP standards.
* Problem solving to get to root cause of issues.
* Provide support with audit/inspection requirements to ensure department compliance/readiness.
* Collaborating with others by sharing your skill set and expertise.
* Drive continuous improvement, perform root cause analysis on system failures e.g. FMEA, Fishbone diagrams, 5 why's etc,
Requirements:
* 1-3 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
* Previous Analytical Experience
* Demonstrated ability to work independently and fully realise improvement initiatives with a moderate level of guidance.
* Good communication, interpersonal skills, and ability to work across teams.