Job Type: Contract
Job ID: JO-1901-12488
Consultant: Karen McHugh
Are you a Senior QA Analyst with 5+ years QA experience, approving Deviation and CA?
If you would like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development, send your CV to firstname.lastname@example.org?
Senior QA Analyst - CAPA - Amgen - 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.
Aseptic experience is not essential for this role but candidates must have a pharma or biotech background
They will need to have at least 5 years QA experience, approving Deviation and CAPAs
Quality mindset and self motivated and take ownership of processes and work with managers across different functions within the business
Looking for someone who can hit ground running Needs to have audit experience, either on their own site or dealing with regulators Candidates need to be flexible in line with audits that are conducted so many need to work additional hours, there maybe some scope to WFH (when audits aren't taking place)
QA Specialists may be assigned specific oversight & responsibilities for key QA Specialist
The QA Specialist is a senior & active role within the broader QA function.
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 quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, IS, Manufacturing, Process Development, Validation, Engineering and QC. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
Perform all activities in compliance with Amgen safety standards and SOPs
Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Write, review and approve SOPs 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 NCs 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.
QA Specialist Quality Systems and Compliance (may perform some of 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 Mgmt , Change Control, NC/CAPA processes, Internal auditing/self-inspection program, Complaints , Quality Mgmt Systems and the overall Quality Mgmt review process.
Ensures 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 Mgmt of Quality Risk Mgmt 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, NC/CAPA processes, Documentation Mgmt
Responsible for trending programs associated with NC/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.
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.
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
Contract rate of €40 - €55 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or call +353-1-7978720
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