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Barden are delighted to be supporting our Global healthcare client in their search for Quality Specialist.
ABOUT THE ROLE:
This position is hybrid offering 3 days remote a week. The Quality Specialist will ideally have experience in an FDA or EU regulated pharmaceutical environment, preferably in a manufacturing site
Key Responsibilities:
- Support the Quality Manager / RP and QP in maintaining compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
- Assist the Quality Manager/ RP and QP in the development of continuous improvement and compliance projects within the Quality Department.
- Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.
- Assist in the completion of internal audits of GMP/GDP 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.
- 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 – including investigations, reporting, and trending.
- Assist in the co-ordination and documentation of product recalls and mock recalls.
- Support Pharmacovigilance, Medicovigilance and Compliance activities as required.
- Responsible for issuing protocol and report numbers and maintaining associated logs.
- Compilation of reports in a timely manner, as requested.
- Assigning resources to all investigations, ensuring the acquisition of the necessary information.
- Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated.
ABOUT THE PERSON:
Skills & Expertise:
- 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.
- Bachelor’s degree or higher within a Science discipline.
- 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.
- Knowledge of local regulatory/code requirements.
- Knowledgeable in Industry Best Practices for quality and compliance related topics.
- Ability to process technical information.
- Accuracy and excellent attention to detail are key attributes along with strong organisational skills.
- Proven ability to effectively initiate and drive change.
- Proficiency in the English language; strong verbal and written communication skills is essential.
