Amgen Plant Quality Assurance Specialist in Dublin, Ireland
Plant Quality Assurance Specialist
The Plant QA Specialist reports to PQA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. PQA specialists will be required to understand and grasp a broad range of quality related competencies.
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.
Plant QA Specialist Responsibilities
Perform all activities in compliance with Amgen safety standards and SOPs
Provide Quality direction and input at Change Control and Deviation meetings and assume oversight of Change Control, Deviation and CAPA records; ensuring scope of record is clear, impact is well understood and defined and implementation activities are robust and timely.
Write, review and approve SOPs in accordance with Amgen Policies.
Participate in site activities associated with the Quality Management System (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
Provide Quality oversight of the Maintenance programs within the Plant
Participates in customer complaint investigations.
Provides training and advice to staff in order for them to perform their desired functions.
Observe and provide real-time quality oversight, Subject Matter Expertise and support for production unit operations, extending to formulation, vial and syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions
Collaborate with Operations to resolve Quality and Compliance matters
Review and approve cGMP records (e.g., electronic batch record, change controls, Deviations, CAPAs, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
Lead Continuous Improvement initiatives
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.
University degree. 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.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Experience working with dynamic cross-functional teams and proven abilities in decision making
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
Excellent written and verbal communication skills
Strong organizational skills, including ability to follow assignments through to completion