QA Specialist

Morgan McKinley; Swords; On-site; EUR 60,000 - 80,000; Full time

Job summary

Morgan McKinley is seeking a Quality Assurance professional for an onsite role in Ireland. The successful candidate will provide direct QA support to production, ensure data integrity on the shop floor, and review GMP documentation for accuracy.

You will review electronic batch records, support commissioning and qualification lifecycle documents, and assist with PQ/Process Validation activities, CAPAs, deviations, and audits as part of a cross-functional team.

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3 years of GMP environment experience post-degree.
• Understanding of cGMPs and regulatory requirements.
• Leadership and strong communication skills.
• Ability to coach and upskill a team.
• Analytical aptitude and problem-solving skills.

Responsibilities

• Provide direct quality support to production and support areas.
• Presence on the shop floor to support compliance and data integrity.
• Review and approve GMP documentation/data for accuracy.
• Review and approve electronic batch records and logbooks.
• QA support for commissioning/qualification lifecycle documents.
• QA support for PQ and Process Validation activities.
• Support sustaining and QC activities such as CAPA, deviations, and calibration programs.
• Provide support to internal audits and regulatory inspections.
• Collaborates with cross-functional teams on continuous improvement initiatives.

Skills

Leadership

Communication

Interpersonal skills

Problem solving

Analytical thinking

Education

Bachelor's degree in science or engineering

Job description

This role is Onsite only.

Qualifications:

General Competencies:

• Leadership skills coupled with good oral and written communication skills.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.

Technical:

• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Minimum Education/Experience:

• Bachelor's degree, in a scientific or engineering field.
• 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.

Responsibilities:

• Provide direct Quality support to production and support areas.
• Provides presence on the shop floor to support compliance and data integrity.
• Review and approve GMP documentation/data for accuracy and completeness.
• Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• QA support, review, and approval for Performance qualification (PQ) & Process Validation activities across site.
• Support sustaining and QC activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance and Calibration Programs.
• Provides support to internal audits and regulatory inspections.
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans