Quality Assurance Specialist

Collins McNicholas Recruitment & HR Services Group; Dublin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Collins McNicholas Recruitment & HR Services Group is assisting a global specialty pharmaceutical company based in Dublin to hire 2 Quality Assurance Specialists. The role supports Manufacturing Operations and maintains the QMS within the facility, including investigations of deviations and out-of-spec events.

The position requires a scientific degree, 2+ years in a cGMP environment, strong communication, and the ability to lead or support cross-functional investigations with a focus on

Qualifikationen

• Bachelor’s degree or higher in a scientific discipline (Biology, Chemistry, or Engineering).
• Minimum 2 years in a cGMP environment.
• Strong communication and mentoring abilities.
• Ability to adapt to change and work independently.
• Statistical analysis and data interpretation skills.

Aufgaben

• Monitor day to day operations to ensure procedures are followed and identify gaps.
• Review manufacturing records for completeness and compliance before product release.
• Review and approve raw materials, intermediates used in manufacturing.
• Perform and evaluate trending of the QMS to support investigations and continuous improvement.
• Interpret and apply all applicable regulatory requirements.
• Lead or support investigations through cross functional teams.
• Present investigations and provide disposition recommendations to site leadership and QP.
• Improve procedures to align with cGMP and regulatory requirements.
• Review and approve procedures, protocols and reports.
• Lead continuous improvement and site projects in quality/operations.
• Participate in internal/external audits as an SME or audit team member.
• Provide shift support to ensure adequate Manufacturing Operations support.
• Approve GMP impacting changes on site.

Kenntnisse

Communication skills

Interpersonal skills

Presentation skills

Independent worker

Ausbildung

Bachelor's degree in science

Jobbeschreibung

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 2 Quality Assurance Specialists for their expanding team. The QA Specialist is responsible for support of the Manufacturing Operations department and maintenance of the QMS within the manufacturing facility. This position will have a wide range of tasks which include on the floor support, performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events. This role will require shift work.

Responsibilities:

• Monitor day to day operations to ensure procedures are followed, identify gaps, and elevate issues that may impact product quality or regulatory compliance.
• Review manufacturing or operational record for completeness and compliance before product release.
• Review and approve all raw materials, intermediates used in manufacturing.
• Perform and evaluate trending of the QMS to support management reviews, investigations, and continuous improvement initiatives.
• Interpret and properly apply all applicable regulatory requirements
• Lead and/or support investigations through cross functional team involvement.
• Present investigations and deliver disposition recommendations to site leadership and QP.
• Improve existing procedures or create new procedures to align with cGMP and regulatory requirements.
• Review and approve procedures, protocols, reports, etc., as required.
• Lead and/or assist with continuous improvement, compliance-based, and site projects
• Support lean manufacturing initiatives both at the site level and within the greater Quality/Operations organization.
• Participate in internal/external audits as an SME or member of the audit team.
• Provide shift support as and when required to ensure sufficient support the Manufacturing Operations Department.
• Approval of Change Proposals for GMP impacting changes on site at CPMF.

Requirements:

• Bachelor’s degree or higher in a scientific discipline, such as Biology, Chemistry or Engineering.
• Minimum of 2 years’ experience working in a current Good Manufacturing Practice (cGMP) environment.
• Strong communication, presentation and interpersonal skills, with the ability to coach and mentor colleagues effectively.
• Ability to adapt to change, demonstrate initiative and work independently while exercising sound judgement and decision-making.
• Working knowledge of statistical methods, with the ability to analyse, trend and interpret data to support decision-making and continuous improvement.