Job Description:
This role is a permanent, full-time position and will report to the QA Manager.
A QA Specialist Compounding Services is responsible for completing tasks pertaining to compliance and product quality.
Key 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.
* 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 3^rd 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 realise 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.