Quality Assurance Specialist with Spanish

On behalf of our client, a privately owned pharmaceutical company, we are currently recruiting for a Quality Assurance Specialist with Spanish. This is a hybrid role that can be based in the South Dublin Office or Richmond, London office.

ROLE PURPOSE

To manage and coordinate quality aspects of the business, ensuring quality compliance throughout the business. Responsible areas include supplier and customer compliance, compliance with GDP and GMP guidelines, Quality systems compliance and maintenance (SOP/CC/DR), Employee training and SOP compliance

RESPONSIBILITIES

Supplier / Customer compliance

·      Ensure Quality Assurance (QA) business and regulatory requirements are met at all times by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in company Health GMP and WDA licences, in order to support business continuity.

·      Co-ordinate the collation and review of supplier licences and certificates.

·      Ensure medicinal products procured, held and distributed are as authorised by WDA of company, storage premises and customers.

·      Manage authorised activities to ensure operations do not compromise the product quality and remain in compliance with GDP & GMP.

·      Ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, medical devices, unlicensed imports, parallel imports and controlled drugs – where applicable to the WDA & MIA.

Product Quality Compliance

·      Co-ordinate the collation and review of product quality documentation and technical data in order to check that products remain safe, compliant and of a high standard for supply.

Quality System Maintenance & Management

·      Responsible for the management and maintenance of the Health Quality system, ensuring measures are in place to support good documentation practice and data integrity principles, and effective governance of all company SOPs.

·      Maintenance for the awareness of new and revision to existing quality directives within EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use. (E.g. Falsified Medicines directive 201162EU, Directive 2003/94/EC and EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines. Awareness and understanding of Commission guideline 2013/C343/01.)

Documentation

·      Ensure procedure for the retention of documentation with procedures comprehensively written and understood by applicable staff

Complaints, returns, suspected falsified medicinal products and medicinal product recalls

·      Ensure effectiveness of procedure for identification and documented reporting of product quality complaints, product recalls and handling of suspected falsified medicines.

·      Support decisions on the final disposition of returned, rejected, recalled or falsified products (IE customers only;

·      Support approving any returns to saleable stock (IE customers only).

·      ensuring that relevant customer complaints are dealt with effectively.

·      coordinating and promptly performing any recall operations for medicinal products;

Operational management

·      Monthly KPIs for batch release performance monitoring

·      Batch release co-ordination for MIA products: prioritization based on Supply chain demand

·      Samples management: documentation review, shipment follow-up and notification to QC testing sites

·       Site of Importation performance monitoring and corordination includes documentation preparation for sampling activities and deliveries

Requirements

·      Degree level in a Life Science subject or equivalent in relevant experience.

·      Able to communicate effectively in English and Spanish for technical discussions

·      Knowledge of Quality Management system within a pharmaceutical background.

·      Good understanding of GMP / GDP.

·      Good understanding of pharmaceutical regulation and regulators.

·      Good inter-personal and communication skills

·      Ability to work under pressure and to tight time deadlines.

·      Excellent attention to detail.

·      Ability to prioritise work.

·      Effective time management.

·      High level of IT skills.

·      Relevant knowledge and experience related to the distribution of medicinal products

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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