QC Senior Specialist

We're looking for a QC Senior Specialist to join our Quality Control team in Ballytivnan in Sligo. You'll report to the QC Lab Manager and be the technical subject matter expert (SME) for the QC laboratory. You'll also be the main contact for any issues in the analytical lab. You'll mostly manage your own work, with a high level of autonomy and no direct reports. You'll give technical guidance across the site, work with cross-functional teams and people at all levels, and help make sure the lab stays fully compliant.
Responsibilities
Support the transfer and validation of analytical test methods.
Implement and qualify new laboratory equipment, and make sure existing equipment is maintained according to the procedures that govern it.
Make sure laboratory documentation and computerised systems comply with data integrity policies and regulatory requirements.
Provide technical input for the lab's analytical work during regulatory inspections, so the lab stays fully compliant at all times.
Review pharmacopoeia requirements on an ongoing basis, and develop and update in-house lab procedures to meet them.
Generate and manage all analytical technical reports.
Manage the lab's change management process, and oversee CAPA actions so they're completed on time.
Lead analytical OOS issues and lab-related investigations, so normal lab activities resume quickly with minimal disruption.
Handle day-to-day issues in Quality Control.
Identify weaknesses in lab performance and work with lab management to fix them.
Carry out or support projects as directed by lab management, including cross-functional and cost improvement projects.
Give the site technical guidance on analytical issues, and bring technical expertise to cross-functional teams.
Develop training material and train QC analysts. Provide cross-training and guidance on technical analytical methods to new and existing team members.
Build your expertise in current and future analytical techniques.
Contribute positively to departmental programmes.
Comply with all EHS policies, procedures and standards. This includes reporting incidents and near misses straight away, suggesting EHS improvements, attending required EHS training and medical surveillance, and wearing PPE as required.
Other duties as assigned.
At least 5 years of analytical experience in the pharmaceutical industry.
A third-level qualification in a relevant science discipline.
Previous industry experience, with a proven track record in an analytical role.
Experience in a GLP/GMP environment, and knowledge of current cGMP and EU/FDA/ICH/HPRA guidelines.
A high level of expertise in analytical equipment, processes and current best practices.
SME-level knowledge of HPLC, Identification, Conductivity, Protein Concentration, Osmolality and pH.

Employment type
Full-time

Work arrangement
No