Quality Associate Specialist


The Quality Associate 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.

Role Functions

• 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.

Experience, Knowledge & Skills

General competencies:

• Motivation to be an inspiring member of a high performing team.
• 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.

 

Technical competencies:

• Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
• Technical writing skills.
• Lean Six-sigma and problem solving tools.

Education/Experience:

• Bachelor 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.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.