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Atualizado 15/12/2022
- Quality Assurance
- Chemicals
Sobre o nosso cliente
Large multinational.
Descrição
- Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always "audit ready"
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities
- Act as a catalyst for change and improvement in performance/quality
- Provide an example of professionalism and leads the induction and training of new colleagues within the area
- Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR
- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured
- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports
- To authorize the release for sale of finished products (applicable to site without QP)
- Prepare for and support internal and external site audits and inspections, leading regular reviews and periodically following-up action plans as necessary
- Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations
- Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate
- Close open deviations and propose CAPAs based on the outcome of periodic follow-ups
- Prepare SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate
- Approve IOPs, process master documentation and product specifications as required and appropriate.
- Ensure that SOPs and IOPs are up to date, compliant and supports efficient production
- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements
Perfil ideal
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory)
- Typically requires 5-8 years of relevant experience within a QA GMP environment within the Pharmaceutical Industry (mandatory)
- Experience of working in a GMP operational environment (mandatory)
- Training and experience of GMP standards (mandatory)
- Experience of working with Regulatory Affairs and a well-rounded knowledge of the function (mandatory)
- Advanced knowledge of GMP practices with the ability to solve complex problems.
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
- Advanced documentation skills and attention to detail
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
Vantagens
A great professional opportunity.
Pesquise mais Ofertas
Pedro Prata
Quote job ref
JN-102022-5781676
Resumo da Função
- Subsetor
- Químico/Processo
- Indústria
- Healthcare / Pharmaceutical
- Localização
- Lisboa
- Tipo de contrato
- Indefinido
- Nome do Consultor
- Pedro Prata
- Referência da Oferta
- JN-102022-5781676
