Job Type: Contract
Job ID: JO-1908-19237
Consultant: Karen McHugh
Do you have 5yrs + experience working in the pharmaceutical or biotechnology industry in Quality Assurance? Do you have experience of New Product Introductions, Technology Transfer and Process Validation activities?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Quality Assurance Specialist - NPI - Biotech - Dun Laoghaire - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
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 ADL, 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.
QA TS Specialist Responsibilities: (may perform some or all of these duties)
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 Amgen 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 Amgen 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 Amgen 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 Amgen 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
5yrs + experience working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but they would need to have aptitude, be self motivated with a QA or validation background
University degree. Engineering or Science related discipline.
Experience working with dynamic cross-functional teams and proven abilities in problem solving and decision making
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.
Excellent Hourly Rate
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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