Collins Management Support jobs

Our client is a global specialty pharmaceutical company focused on developing and commercialising medicines for rare diseases and complex medical conditions, with a strong commitment to innovation and improving patient outcomes.

Based in Dublin, we are looking to hire a Quality Control (QC) for their expanding team.

This is a lab based role.

The Quality Control (QC) Analyst is responsible for performing and supporting laboratory testing activities The role ensures that all testing, documentation and laboratory operations comply with applicable regulatory requirements, quality standards and best practices, while supporting the timely delivery of reliable results to internal and external customers.

Essential Functions and Responsibilities

• Perform routine QC testing of raw materials, intermediates, finished products and stability samples in accordance with approved methods and established testing schedules.
• Draft, review and maintain controlled documentation, including Standard Operating Procedures (SOPs), protocols, training materials, investigation reports and other Quality Management System (QMS) documents.
• Participate in analytical method transfers, method validation and method development activities as required.
• Conduct, document and support investigations into out-of-specification (OOS) and out-of-trend (OOT) results, ensuring appropriate investigation, escalation and follow-up.
• Support the day-to-day operation and organisation of the QC laboratory, ensuring equipment, materials and resources are maintained in a suitable state for use.
• Apply analytical techniques including wet chemistry, gas chromatography (GC) and high-performance liquid chromatography (HPLC), with the ability and willingness to learn additional techniques as laboratory requirements evolve.
• Manage testing activities in line with the facility’s testing schedule, stability programmes and operational priorities.
• Ensure laboratory activities are performed in accordance with approved procedures, data integrity requirements, good documentation practices and applicable regulatory standards.
• Maintain accurate, complete and traceable laboratory records and ensure results are documented and reported in a timely manner.
• Work collaboratively with cross-functional teams to support manufacturing, process development, investigations and continuous improvement activities.

Minimum Requirements

Education and Experience

• Minimum BSc in Science or a relevant scientific discipline.
• At least 3 years’ experience in a similar laboratory role, including experience within a Quality Control environment.
• Practical experience with analytical laboratory techniques, including LC-MS/MS and GC preferred.
• Experience in analytical method validation and/or method development.
• Experience in pharmaceutical manufacturing, drug development or process development is desirable.
• Experience working within a regulated laboratory environment, with an understanding of applicable quality and compliance requirements.

Technical Skills and Competencies:

• Good computer skills, including proficiency in Microsoft Word, Excel, PowerPoint and Access, as well as relevant laboratory and business systems such as SAP and Empower.
• Strong technical writing skills, with the ability to prepare clear, accurate and compliant documentation.
• Excellent analytical and problem-solving skills, with the ability to investigate issues, interpret results and make sound decisions.
• Ability to plan, organise and prioritise testing activities effectively to meet laboratory and facility deadlines.
• Ability to identify priorities, manage competing tasks and recognise when issues require escalation.
• Strong written and verbal communication skills, with the ability to communicate technical information clearly and effectively.
• Good attention to detail and a commitment to data accuracy, documentation quality and regulatory compliance.

CMCNPRO1

For further details on this position please contact

Or call Gillian on 090 6478104

Pay: €45,000.00-€55,000.00 per year

Benefits:

• Company pension
• On-site parking
• Private medical insurance

Work Location: In person