MSD Intern Placement - QA Operations Specialist 

Ireland, Dublin 

252178255

Job Description

The Quality Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.

The following would be the primary 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 C&Q, Performance qualification (PQ) & Process Validation documents.
• Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & 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.

The following would be the general competencies required;

• Working towards a science or engineering degree
• Motivation to be an inspiring member of a high performing team and passion to build the future of one of our Dublin sites.
• Desire to continuously learn, improve and develop.
• 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.
• The following would be the technical skills required;
• Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
• Technical writing skills.
• Lean Six-sigma and problem solving tools.

Current Contingent Workers apply

Intern/Co-op (Fixed Term)

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.