Compliance Specialist

Compliance Specialist

Industry : Pharmaceutical

Job Responsibilities:

• Co-ordinating the Complaints / Quality Defect Reporting Systems, including but not limited to the initiation of complaint /Quality Defect Reports (QDRs), consulting with relevant parties, leading/participating in investigations, agreeing appropriate CAPA etc.
• Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a supplier or other element of the role.
• Reviewing / leading Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure any such investigations are documented appropriately with relevant CAPA, if necessary.
• Co-ordinating of local regulatory activities including update/ maintenance of the Site Master File, the company manufacturing authorisations, and other relevant documents.
• Co-ordinating of the Supplier Quality Management System, including conducting supplier audits, reviewing supplier documentation, generating / reviewing Quality Agreements, co-ordination of the supplier notification system, conducting periodic reviews of suppliers etc.
• Co-ordinating any site regulatory audit readiness programs, including managing the front room, collating audit responses, agreeing CAPA, etc.
• Supporting QP certification activities (i.e., batch record review, IMP Order authorisation, Product Specification File maintenance, etc.)
• Ensuring all QMS commitments are met by conducting the required actions, providing all necessary supporting documentation etc.
• Supporting the review and approval of Quality System /Compliance documents e.g., Deviations, Change Controls, CAPA, SOPs, Protocols, Reports etc.
• Co-ordinating and participating in the company self-inspection system, including conducting walkdowns /process /internal audits, authoring reports, consulting with stakeholders, agreeing appropriate CAPA, conducting trend analysis etc.
• To identify, develop, establish, implement, maintain, and continually improve quality processes, methodologies, systems, and practices to meet regulatory and corporate requirements.
• Generating /Updating Quality Procedures and other documents to ensure current best practices.
• Supporting New Project Introduction /Technology Transfer projects as required.
• Preparing Annual Product Quality review reports.
• Supporting the Quality Management Review process by providing required KPI data, etc.
• Supporting / leading projects including working as part of a multidisciplinary team as required.
• Contributing to the overall improvement of the company from a Quality / GMP / Compliance perspective with an emphasis on continuous improvement of the quality system.
• Any other duties assigned by Quality Management.

Qualification and Experience Requirements:

• Minimum of a bachelor’s degree in a science / quality -based discipline with a minimum of 10 years experience in a pharmaceutical finished drug product manufacturing environment with working knowledge of EU GMP, US FDA, Other Guidelines/Regulations.
• Excellent knowledge and understanding of current / pending EU GMP and US FDA regulations, standards and requirements for Active Pharmaceutical Ingredients, Excipients, Drug Products, Devices /Combination /Sterile Products, etc. and ensuring compliance with same.
• Excellent professional / technical writing skills and computer literacy.
• Strong communication and presentation skills (verbal / written).
• A proven self-starter with advanced organisational skills and attention to detail.
• Strong people skills, with the ability to work co-operatively and effectively with others to establish and maintain good working relationships.

Location:  Co Tipperary

Duration:  Permanent with 6 months probationary period.