QC Specialist

Orion Group Life Sciences are currently recruiting a QC Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.
 
This role is Onsite only.

Responsibilities:

• Provides presence on the shop floor to support compliance and data integrity.
• Provide direct Quality support to production and support areas.
• 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

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.

 
 


People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.