The QA Specialist will be required to be a Subject Matter Expert in their assigned area of responsibility
Senior Quality Assurance Professional - Bio-pharmaceuticals- Dublin
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.
In addition to routine Quality Assurance duties, QA TS Specialist may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for products or functional areas within the site, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. QA TS Specialist may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
* Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and expectations.
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet company and regulatory expectations.
* Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA 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 in accordance with company Policies.
* Review and approval of Master Batch Records and SAP BOMS
* Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
* Perform all activities in compliance with company safety standards and SOPs
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
Education and Experience:
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but they would need to have aptitude, self motivated with a QA or validation background
* Excellent written and verbal communication skills
* Strong organizational skills, including ability to follow assignments through to completion
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
* Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
* Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.