Quality Specialist (Hybrid)

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.