We are currently collaborating with our client, B. Braun, one of the world's leading health care suppliers and is in the Top 20 ranking of Medical Device Companies. They are currently recruiting for a QA Specialist Compounding Services. This role is a permanent, full-time position and will report to the QA Manager. This is a hybrid role, based in the Dublin 12 office.
In this role your core responsibilities will include:
A QA Specialist Compounding Services is responsible for completing tasks pertaining to compliance and product quality. The QA Specialist Compounding Services will provide quality oversight and collaborate with all relevant departments to ensure that key quality systems are operated in compliance with GMP and the associated regulatory requirements for the compounding services business in Ireland. This will include documentation management and approval, product quality review, investigations, complaints, change controls, audits and stability studies.
Responsibilities:
- Support the Quality Manager/ RP and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), Good Distribution Practice for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
- Assist the Quality Manager/RP and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department. For example - Support projects as the business expands within the compounding services division.
- Document Management System - Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.
- Prepare information in advance for presentation at the Quality Review Board meetings.
- Assist in the completion of internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.
- Ensuring the GMP and GDP elements of the Quality Management system (QMS) is understood by providing training to personnel regarding updated documents.
- Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person.
- Quality Risk Management - Assisting Process Owners in assessing risks and assigning counteractive measures.
- Conducting Supplier Audits and Assessments, as required.
- Managing and updating Technical Agreements.
- Documenting and managing relevant change controls through to completion.
- Ensure the adherence to the stability schedule & management of the stability data for the support of the expiry dates.
- Co-ordinate customer and supplier complaints related to the MIA - including investigations, reporting, and trending in collaboration with the Qualified Person.
- Responsible for issuing protocol and report numbers and maintaining associated logs. Compilation of reports in a timely manner, as requested.
- Assist in the co-ordination and documentation of recalls and mock recalls.
- Assigning resources to all investigations, ensuring the acquisition of the necessary information.
- Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated.
Qualifications/Requirements:
- Bachelor’s degree or higher preferred; ideally in a related Science discipline
- 3-5 years’ experience in a pharmaceutical/regulated background with strong working knowledge of GMP, regulatory expectations, and familiarity with aseptic processing.
- Demonstrated ability in quality systems support
- Knowledge of EU quality related pharmaceutical regulations
- Experience of a MIA-Environment
- Experience in dealing with 3rd party warehouse distribution models
- Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality system role
- Knowledge of local regulatory/code requirements
- Knowledgeable in Industry Best Practices for quality and compliance related topics
- Proven ability to effectively initiate and drive change
- Strong verbal and written communication skills, project management skills
- Report, standards, policy writing skills required
- Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems)
- Good collaboration skills
- Ability to work as part of a team to determine priorities
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to drive the completion of tasks
- Proven decision-making capability with accountability and responsibility
- Demonstrated ability to solve problems.
For full job spec and information please send your CV to [email protected] or call Linda at 01 2784703. Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com
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