PE Global is currently recruiting for a Quality Specialist on behalf of a leading biotech company based in Dublin.
This is an initial 11-month contract role and is a shift role
Role Description
This is a shift role (4 x 12hr extended days followed by 4 days off).
The Quality Specialist provides direct quality support to a production area as part of a Quality IPT (Integrated Product Team).
With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.
The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance.
The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations.
Additionally, 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 first time, and to ensure compliance with cGMPs and regulatory requirements.
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: 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
Drive continuous improvement and utilise problem solving tools and MPS (Merck Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Experience, Knowledge & Skills
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 and 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
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
Qualifications & Education
Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
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