Quality Specialist

Orion Group Life Sciences are currently recruiting a Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend. Shift Role.

4 on 4 off Days only shift pattern 06:45am - 7pm 20% shift premium

Role Functions:

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures 
• Provides presence on the shop floor to support compliance and data integrity
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
• Participates as the quality member on cross functional projects
• Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
• 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/Requirements
Required

• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
• Evidence of leadership skills coupled with good oral and written communication skills 
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
• Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience

Preferred

• Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills
• Demonstrated ability to upskill/coach others
• Experience working on manufacturing shop floor
• Familiarity with GMP documentation review and/or shop floor auditing  

 


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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.