<p class="au-target job-description show">                   We are looking for an Associate Manager, Quality Assurance to lead a QA team, ensuring compliance with internal and client processes. Oversee daily operations, manage staff development, and support regulatory audits. Ideal for candidates with leadership experience and knowledge of pharmaceutical quality standards.                  </p>                  

&lt;p style="text-align:left"&gt;&lt;b&gt;Work Schedule&lt;/b&gt;&lt;/p&gt;Standard (Mon-Fri)&lt;p style="text-align:inherit"&gt;&lt;/p&gt;&lt;p style="text-align:left"&gt;&lt;b&gt;Environmental Conditions&lt;/b&gt;&lt;/p&gt;Adherence to all Good Manufacturing Practices (GMP) Safety Standards&lt;p style="text-align:inherit"&gt;&lt;/p&gt;&lt;p style="text-align:left"&gt;&lt;b&gt;&lt;u&gt;Job Description&lt;/u&gt;&lt;/b&gt;&lt;/p&gt;&lt;p style="text-align:inherit"&gt;&lt;/p&gt;&lt;p&gt;As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;&lt;u&gt;&lt;span&gt;Position Summary&lt;/span&gt;&lt;/u&gt;&lt;/b&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;This role is available within the QA Operations department at Thermo Fisher Scientific, Swindon.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;The QA Validation &amp; Qualification Documentation Reviewer supports the QA review of qualification and validation documentation across defined GMP validation activities. The role focuses on ensuring that assigned documents are complete, accurate, traceable, and aligned with approved procedures, protocols, acceptance criteria, change controls, and GMP documentation expectations.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;The role includes review of documentation generated by Commissioning &amp; Qualification, Requalification, MSAT, Quality Control, Engineering, Operations, and other relevant site teams. Documentation may include equipment qualification, utilities and facilities qualification, computerized system validation, process validation, cleaning validation, aseptic process simulation, requalification, revalidation, and lifecycle review records.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;The individual will identify documentation gaps, provide clear review comments, support timely resolution with cross-functional teams, and escalate complex technical, regulatory, scientific, or data integrity concerns to senior QA colleagues, subject matter experts, QA management, or the Qualified Person where applicable.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;This 5 role provides QA documentation review and assigned approval support while developing broader validation, qualification, and GMP regulatory judgement.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;&lt;u&gt;&lt;span&gt;Responsibilities&lt;/span&gt;&lt;/u&gt;&lt;/b&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To perform QA review of assigned qualification and validation lifecycle documents, including:&lt;/span&gt;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;&lt;span&gt;Validation Master Plans or local validation plans&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;User Requirement Specifications&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Risk assessments&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Process Performance Qualification and process validation protocols and reports&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Cleaning validation documentation&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Aseptic Process Simulation / Media Fill documentation&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Computerized system validation packages&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;QC Chemistry and Microbiology qualification or requalification documents&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Equipment, utilities, facilities, and engineering qualification documentation&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Requalification, revalidation, and lifecycle review documents&lt;/span&gt;&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;&lt;span&gt;To verify that assigned documents include clear scope, predefined acceptance criteria, traceability to user and GMP requirements, defined responsibilities, appropriate data integrity controls, documented deviation handling, and conclusions supported by objective evidence.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To confirm that validation and qualification documentation is aligned with approved procedures, protocols, change controls, deviations, investigations, CAPA records, and other relevant GMP documentation.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To support QA review of computerized system validation documentation, including intended use, risk assessment, user access controls, data integrity controls, backup and restore considerations, change control, and testing evidence.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To assess basic data integrity expectations within validation and qualification packages, including traceability of raw data, completeness of supporting evidence, consistency of results, and alignment between protocols, deviations, reports, and final conclusions.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To review qualification and validation deviations, failed acceptance criteria, discrepancies, and protocol variations to confirm that investigations, impact assessments, CAPA requirements, and final conclusions are complete before document approval or closure.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To review change controls for potential impact on qualified or validated status and identify whether requalification, revalidation, regression testing, or continued verification may be required, escalating complex decisions where appropriate.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To support periodic or lifecycle review of qualified equipment, utilities, systems, and validated processes by reviewing assigned documentation and identifying gaps, overdue actions, or evidence requiring escalation.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To raise clear, objective, and timely comments on documentation deficiencies and support cross-functional teams in resolving review observations.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To support QA review and approval workflows within applicable document management or quality systems, in line with training, procedures, and assigned QA approval authority.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To collaborate with CQV, MSAT, Engineering, QC, Operations, and QA colleagues to support timely completion of validation and qualification documentation.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To contribute to the maintenance and improvement of document review checklists, templates, and ways of working.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To maintain awareness of applicable GMP requirements, internal procedures, and site expectations related to validation, qualification, computerized systems, documentation, data integrity, deviation/CAPA, and change control.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;To escalate unresolved GMP risks, data integrity concerns, unjustified deviations, inadequate validation evidence, or potential product quality impact to senior QA, QA management, and the Qualified Person where applicable.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;&lt;u&gt;&lt;span&gt;EH&amp;S:&lt;/span&gt;&lt;/u&gt;&lt;/b&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;Understand and ensure implementation of emergency procedures and safe systems of work. Ensure compliance with environment, health and safety rules, signage and instructions at all times. Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;&lt;u&gt;&lt;span&gt;Minimum Requirements/Qualifications:&lt;/span&gt;&lt;/u&gt;&lt;/b&gt;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;&lt;span&gt;Science based degree e.g. BSc or MSc&lt;/span&gt;&lt;/li&gt;&lt;li&gt;Some experience in validation document review within the pharmaceutical industry, preferably in sterile manufacturing.&lt;/li&gt;&lt;li&gt;&lt;span&gt;Proficient knowledge of process validation, cleaning validation and continuous process improvement.&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Knowledge of mainstream statistical software analysis programs such as MiniTab.&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Solid understanding of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Technical writing skills - Deviations, reports, investigations, SOPs. &lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Excellent interpersonal skills, communication, and organizational skills&lt;/span&gt;&lt;/li&gt;&lt;li&gt;&lt;span&gt;Ability to multi-task, meeting tight deadlines.&lt;/span&gt;&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;

QA Validation & Qualification Documentation Reviewer

Thermo Fisher Scientific

Regulatory Affairs vacatures zijn baanposities binnen een organisatie die zich bezighouden met het voldoen aan de regelgeving en wetgeving die van toepassing is op producten en diensten. Regulatory Affairs professionals werken in verschillende sectoren, waaronder de farmaceutische, medische hulpmiddelen, voedingsmiddelen, cosmetica en chemische industrie. Ze zijn verantwoordelijk voor het zorgen dat producten en diensten voldoen aan alle nationale en internationale regelgeving en normen. Ze adviseren en ondersteunen de organisatie bij het verkrijgen van de benodigde vergunningen, certificaten en goedkeuringen.

Job inden for Regulatory Affairs omfatter stillinger dedikeret til lægemidlers regulatoriske overholdelse. Disse fagfolk fortolker myndighedskrav, håndterer registreringsdossierer og markedsføringstilladelser og varetager kontakten til sundhedsmyndigheder som Lægemiddelstyrelsen og EMA. De sikrer, at produkterne opfylder alle nationale og internationale krav til kvalitet og sikkerhed.

Regulatory Affairs Stellenangebote beziehen sich auf Positionen in Unternehmen, die sich mit der Einhaltung gesetzlicher Vorschriften und Regularien in verschiedenen Branchen befassen. In diesen Rollen sind Fachkräfte dafür verantwortlich, sicherzustellen, dass Produkte und Prozesse den gesetzlichen Anforderungen entsprechen und genehmigt sind. Dies umfasst die Kommunikation mit Aufsichtsbehörden, die Erstellung von Compliance-Dokumentationen und die Gewährleistung der Konformität mit gesetzlichen Bestimmungen. Regulatory Affairs Stellen erfordern in der Regel ein tiefgreifendes Verständnis von Gesetzen und Vorschriften sowie exzellente Kommunikations- und Organisationsfähigkeiten. Wenn Sie nach einer herausfordernden Position suchen, die rechtliche Aspekte mit unternehmerischem Denken verbindet, könnten Regulatory Affairs Stellenangebote für Sie von Interesse sein.

Regulatory Affairs jobs involve ensuring that companies comply with the laws and regulations governing their industries. Professionals in this field are responsible for understanding and interpreting government regulations, evaluating their impact on products or services, and ensuring that all necessary licenses, permits, and approvals are obtained. They also work closely with cross-functional teams within the company to ensure that products are developed and marketed in compliance with applicable regulations, and they provide guidance on regulatory matters to business leaders and stakeholders. Overall, Regulatory Affairs professionals play a vital role in helping companies navigate the complex landscape of regulations and maintain compliance to meet the highest standards of quality and safety.

Empleos en Asuntos Regulatorios: cumplimiento normativo de los medicamentos, gestión de registros y relación con la AEMPS y la EMA.

Les emplois en Affaires Réglementaires concernent des postes dédiés à la conformité réglementaire des produits pharmaceutiques. Ces professionnels interprètent les réglementations gouvernementales, gèrent les dossiers d'autorisation de mise sur le marché (AMM), et assurent la liaison avec les autorités de santé comme l'ANSM. Ils garantissent que les produits respectent toutes les exigences nationales et internationales en matière de qualité et de sécurité.

I lavori in Affari Regolatori riguardano posizioni dedicate alla conformità normativa dei prodotti farmaceutici. Questi professionisti interpretano le normative governative, gestiscono i dossier di autorizzazione all'immissione in commercio (AIC) e curano i rapporti con le autorità sanitarie come l'AIFA. Garantiscono che i prodotti rispettino tutti i requisiti nazionali e internazionali in materia di qualità e sicurezza.

Empregos em Assuntos Regulamentares: conformidade normativa dos medicamentos, gestão de registos e relação com o INFARMED e a EMA.

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Quality vacatures in de farmaceutische industrie zijn functies waarbij de nadruk ligt op het waarborgen van de kwaliteit van geneesmiddelen en medische producten. Deze vacatures zijn essentieel voor de veiligheid en effectiviteit van farmaceutische producten, en vereisen nauwkeurigheid, analytisch denken en kennis van regelgeving.

Een voorbeeld van een quality vacature in de farmaceutische industrie is die van een Quality Assurance Specialist. In deze rol is de specialist verantwoordelijk voor het implementeren en handhaven van kwaliteitssystemen binnen een organisatie. Ze zorgen ervoor dat processen voldoen aan de geldende regelgeving en richtlijnen, en voeren audits uit.

Job inden for kvalitet i medicinalindustrien handler om kvalitetssikring (QA) og kvalitetskontrol (QC) af lægemidler og sundhedsprodukter. Disse fagfolk implementerer og vedligeholder kvalitetsstyringssystemer, gennemfører audits og sikrer overholdelse af GMP og branchens standarder. De spiller en central rolle i at garantere produkternes sikkerhed og effektivitet.

Qualitätsstellenangebote sind Jobpositionen, die sorgfältig ausgewählt und überprüft wurden, um sicherzustellen, dass sie den Anforderungen und Erwartungen der Bewerber entsprechen. Diese Stellenangebote bieten attraktive Arbeitsbedingungen, Entwicklungsmöglichkeiten und ein angemessenes Gehalt. Bei der Suche nach qualitativen Stellenangeboten ist es wichtig, auf seriöse Unternehmen und vertrauenswürdige Quellen zu achten, um eine langfristige und erfüllende Karriere zu gewährleisten.

Pharmaceutical Quality jobs refer to positions within the pharmaceutical industry that are focused on ensuring the quality of pharmaceutical products. These jobs involve implementing and maintaining quality control systems, conducting risk assessments, and overseeing all aspects of the production process to ensure compliance with regulations and industry standards. Responsibilities may include testing and analyzing samples, documenting and reporting findings, and implementing corrective actions when necessary. Pharmaceutical Quality professionals play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products.

Empleos en Calidad farmacéutica: garantía y control de calidad de los medicamentos, auditorías y cumplimiento de las normas GMP del sector.

Les emplois Qualité dans l'industrie pharmaceutique concernent des postes axés sur l'assurance qualité et le contrôle qualité des médicaments et produits de santé. Ces professionnels sont chargés de mettre en œuvre et maintenir les systèmes de gestion de la qualité, de réaliser des audits, et de veiller à la conformité avec les réglementations GMP et les normes du secteur. Ils jouent un rôle essentiel pour garantir la sécurité et l'efficacité des produits pharmaceutiques.

I lavori nella Qualità nell'industria farmaceutica riguardano posizioni incentrate sull'assicurazione qualità e sul controllo qualità dei farmaci e dei prodotti per la salute. Questi professionisti hanno il compito di implementare e mantenere i sistemi di gestione della qualità, condurre audit e garantire la conformità alle normative GMP e agli standard di settore. Svolgono un ruolo essenziale nel garantire la sicurezza e l'efficacia dei prodotti farmaceutici.

Empregos em Qualidade farmacêutica: garantia e controlo de qualidade dos medicamentos, auditorias e cumprimento das normas GMP do setor.

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Productie vacatures in de farmaceutische industrie zijn vacatures waarbij je verantwoordelijk bent voor het productieproces van medicijnen en andere farmaceutische producten. Binnen deze vacatures werk je vaak in een cleanroom omgeving waar hygiëne en veiligheid hoog in het vaandel staan. Je zorgt ervoor dat het productieproces soepel verloopt en dat de producten voldoen aan de kwaliteitseisen. Dit kan onder andere inhouden dat je grondstoffen afweegt, mengt en in de juiste verpakkingen plaatst. Ook controleer je regelmatig de kwaliteit van de producten en voer je eventuele correcties uit.

Job inden for produktion i medicinalindustrien handler om fremstilling af lægemidler og sundhedsprodukter. Stillingerne indebærer arbejde i renrum, streng overholdelse af hygiejne- og sikkerhedskrav og beherskelse af god fremstillingspraksis (GMP). Produktionsmedarbejdere sikrer korrekt gennemførelse af fremstillingsprocessen og kvalitetskontrol af produkterne.

Produktion Stellenangebote umfassen Positionen in verschiedenen Branchen, in denen Mitarbeiter für die Herstellung von Waren oder die Erbringung von Dienstleistungen verantwortlich sind. Typische Jobtitel in diesem Bereich können Produktionsmitarbeiter, Fertigungsingenieure, Qualitätskontrolleure, Produktionsleiter und viele andere sein. Wenn Sie gerne praktisch arbeiten und Teil eines Teams sein möchten, das Produkte herstellt, könnten Produktion Stellenangebote das Richtige für Sie sein. Schauen Sie sich die aktuellen Stellenangebote in diesem Bereich an und finden Sie die passende Position für sich.

Pharmaceutical manufacturing jobs are positions within the pharmaceutical industry that involve the production and manufacturing of pharmaceutical products. This includes the manufacturing, testing, and packaging of drugs or medications, as well as ensuring compliance with quality control standards and regulations. Pharmaceutical manufacturing jobs can range from entry-level positions on the production line to more advanced roles such as process engineers or quality assurance managers. These jobs require knowledge of Good Manufacturing Practices (GMP), strong attention to detail, and the ability to work in a highly regulated and controlled environment.

Empleos en Fabricación farmacéutica: producción de medicamentos en salas blancas con estricto cumplimiento de las buenas prácticas (GMP).

Les emplois en production pharmaceutique concernent la fabrication de médicaments et produits de santé. Ces postes impliquent le travail en environnement salle blanche, le respect strict des normes d'hygiène et de sécurité, et la maîtrise des bonnes pratiques de fabrication (BPF/GMP). Les professionnels de la production assurent le bon déroulement du processus de fabrication et le contrôle qualité des produits.

I lavori nella produzione farmaceutica riguardano la fabbricazione di farmaci e prodotti per la salute. Queste posizioni comportano il lavoro in ambiente di camera bianca, il rigoroso rispetto delle norme di igiene e sicurezza e la padronanza delle buone pratiche di fabbricazione (GMP). I professionisti della produzione garantiscono il corretto svolgimento del processo di fabbricazione e il controllo qualità dei prodotti.

Empregos em Fabrico farmacêutico: produção de medicamentos em salas limpas com rigoroso cumprimento das boas práticas de fabrico (GMP).

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