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Amgen QA Specialist Disposition - 12 month Fixed Term Contract in Dublin, Ireland

Quality Assurance Specialist (Level 05) Amgen Dun Laoghaire – ADL Disposition Team

Job Description:

The Quality Assurance (QA) Specialist will be an active member of the ADL QA team and will serve as the Quality reviewer and approver on GMP documentation. For this role, the QA Specialist QP must be eligible to act in the capacity of a Qualified Person, and their education and background must satisfy the minimum requirements as outlined in Directive 2001/83/EC. The QA Specialist / QP 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 specialists will be required to understand and grasp a broad range of quality related competencies.

In addition to routine QA Assurance duties, QA Specialists 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 functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

QA Specialists may be assigned to a specific Quality functional area, for which the general functional area and duties are outlined below and for which candidates may be required to fulfil one or more of these duties. Additional responsibilities commensurate with QA Specialist level may extend, but not be limited to undertaking one or more other core responsibilities including;

  • Participation in self-inspection program in a lead auditor or auditor capacity

  • Quality Risk Management execution/facilitation

  • Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required

  • Inspection readiness activities and hosting of internal and external Board of Health inspections, inclusive of providing QA technical expertise during audits/inspections

  • Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums

  • Provision of Quality Oversight and partnership for internal and external customers

  • Assuming site or business process owner roles, and active participation at network meetings and external forums

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

General QA Specialist Responsibilities:

  • Perform all activities in compliance with Amgen safety standards and SOPs.

  • Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues.

  • Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures.

  • 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 in accordance with Amgen Policies.

  • 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.

Specific Duties of the QA Specialist within the disposition team: (may perform some or all of these duties)

  • The QP will without prejudice also assume responsibility for the final disposition and certification of product and for ensuring that the batch has been manufactured and checked in accordance with the requirements of the Marketing Authorisation, principles and guidelines of cGMP.

  • Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability, Product Quality Review and GDP.

  • 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.

  • Co-ordinates and approves the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.

  • Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.

The knowledge and skills necessary to perform the duties of the QA Specialist / QP are typically acquired through the following combination of education, experience and knowledge.

Basic Qualifications:

  • Must satisfy requirements outlined in Directive 2001/83/EC to be eligible to act as a QP.

  • University degree in Science or Engineering related discipline.

  • 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.

Preferred Qualifications:

  • 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 / Non Conformance /Deviation investigations

  • Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.

  • Experience working in aseptic operations, protein formulation, vial and syringe filling.

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