Senior Quality Systems Specialist
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3012 |
| Job Views | 856 |
- Description
- Team Horizon is seeking a Senior Quality Assurance Specialist (initial 12-month contract) for our client who are a global biopharmaceutical company based in Dublin. The QA Specialist will typically report to a QA Senior Manager & will be required to be a Subject Matter Expert in their assigned area of responsibility. QA Specialists will be required to understand & grasp a broad range of quality related competencies.
In addition to routine QA duties, QA Specialists may be assigned specific oversight & responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within the client site; including Supply Chain, Operations Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
General QA Specialist Responsibilities:
Perform all activities in compliance with the client’s safety standards and SOP.
Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Write, review and approve Standard Operating Procedures (SOPs) in accordance with the client’s Standards.
Participate in site activities associated with QMS programs (e.g. Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
Participates in customer complaint investigations.
Provides training and advice to staff in order for them to perform their desired functions.
Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations.
Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Quality Systems and Compliance Specialist (may perform some/all of these duties):
Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and auditing related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, Internal auditing/self-inspection program, Regulatory Inspection Management, oversight of computerised systems supporting Quality Management System and the overall Quality Management review process.
Ensuring that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site.
Oversee and maintain site Inspection readiness program and for hosting of inspections (self-inspection and regulatory/corporate inspections).
Manage inspection outcomes, including inspection response compilation and tracking.
Oversee and implement Quality Agreements relating to area of responsibility.
Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines.
Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience and knowledge.
What you need to apply:
University degree in Engineering or Science related discipline preferred.
Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Excellent written and verbal communication skills.
Experience working with dynamic cross-functional teams and proven abilities in decision making.
Strong organizational skills, including ability to follow assignments through to completion.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
Detailed Knowledge of applicable Regulatory requirements.
Experience with Regulatory inspections.
Experience working in aseptic operations, protein formulation, vial and syringe filling.
