1 day ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Berkley Group
Recruitment Consultant - Life Science and Engineering at Berkley Group
Quality Assurance Specialist
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..
Roles & Responsibilities:
* Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
* 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.
* 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 associated to Amgen Quality Systems.
* Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
* Oversight and management of Quality Risk Management (QRM) 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, Deviation/CAPA processes and Documentation Management.
* Responsible for trending programs associated with Deviation/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.
* 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.
* Ensuring 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 site.
Basic Qualifications
* 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.
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 / Deviation investigations.
* Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Contract
Job function
* Job function
Engineering and Quality Assurance
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Berkley Group by 2x
Get notified about new Quality Assurance Specialist jobs in Dublin, County Dublin, Ireland.
Dublin, County Dublin, Ireland 1 hour ago
Senior Quality Assurance QA Specialist - 12 Month Contract
Dublin, County Dublin, Ireland 2 months ago
Dublin, County Dublin, Ireland 2 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 3 days ago
Associate Director - Quality Assurance Lead
Dublin, County Dublin, Ireland 2 days ago
Senior Quality Assurance Systems Specialist
Senior Specialist, QA Drug Substance Disposition
Safety Model Operations Quality Assurance - LATAM Spanish
QA Specialist II (Senior) - External Manufacturing, Combination Products & Quality Compliance
Dublin, County Dublin, Ireland 2 hours ago
Grade VIII Policy and Quality Assurance Manager, NRS14806
Dublin, County Dublin, Ireland 2 weeks ago
EMEA Quality Assurance Associate – Monitoring and Testing
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 2 weeks ago
Quality Assurance Tester, Senior Associate
Dublin, County Dublin, Ireland 5 hours ago
Safety Model Operations Quality Assurance - Italian
Dublin, County Dublin, Ireland 19 hours ago
Freelance Accounting - Quality Assurance/AI Trainer
Dublin, County Dublin, Ireland 2 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Quality Assurance Specialist 3rd Party Products
Blanchardstown, Fingal, Ireland 1 week ago
Quality Assurance Specialist 3rd Party Products
Dublin, County Dublin, Ireland 1 week ago
Grade VIII Policy and Quality Assurance Manager, NRS14806
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dunboyne, County Meath, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 month ago
Dublin, County Dublin, Ireland 6 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr