Quality Assurance Manager

Randstad Portugal; Braga; Presencial; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

High-impact industry

Career advancement opportunities

Resumo da oferta

Randstad Portugal is seeking a Quality Assurance Manager for a fast-growing CDMO focused on cell and gene therapies and biologics. You will ensure GMP and ISO 9001 compliance across production, laboratories, and computerized systems.

You will lead document control, audits, investigations, and continuous improvement while collaborating across departments to uphold quality and regulatory standards.

Qualificações

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences or related field.
• At least 5 years of QA GMP experience in the Pharmaceutical Industry.
• Strong knowledge of GMP, ICH and ISO guidelines and good communication skills.

Responsabilidades

• Ensure compliance with GMP, ISO 9001 and internal/external requirements.
• Oversee document control, regulatory filings and computerized documentation systems.
• Manage records lifecycle: identification, storage, retention and disposition.
• Conduct internal audits; support audits/inspections from clients and regulators.
• Review batch records and investigations for deviations and complaints.
• Promote QA best practices and continuous improvement across functions.

Conhecimentos

GMP knowledge

Quality assurance

Documentation control

Audit experience

English proficiency

Formação académica

Bachelor’s or Master’s in Chemistry/ Biochemistry/ Biology/ Pharmaceutical Sciences

Descrição da oferta de emprego

A Randstad é a empresa mundial líder em talentos. Trabalhamos diariamente para encontrar as melhores oportunidades para os nossos candidatos, ajudando-os a alcançar o seu verdadeiro potencial. Queremos criar um impacto positivo na sociedade, proporcionando oportunidades equitativas para todas as pessoas, independentemente da sua origem, e ajudando-as a manterem-se relevantes num mundo do trabalho em constante mudança.

Our client is an innovative, fast-growing Contract Development and Manufacturing Organization (CDMO) specialized in the advancement of cell and gene therapies (ATMPs) and biologics. Partnering with global leaders across the biotechnology and pharmaceutical sectors, the company bridges the gap between cutting-edge research and successful clinical and commercial translation.

Our client is seeking a Quality Assurance Manager responsible for ensuring strict compliance with GMP and ISO 9001 standards across all production, laboratory, and computerized system processes, while fostering a culture focused on excellence and continuous improvement.

descrição da função/job description

• Ensure compliance with GMP, ISO 9001, and internal/external requirements while promoting process implementation and maintenance;


• Oversee critical document control (approval, revision, updates, distribution) and assist with regulatory filings and computerized documentation systems;


• Manage the complete lifecycle of records (identification, storage, protection, retrieval, retention time, and disposition);


• Comply with internal regulations and the company's code of conduct;


• Conduct internal audits to monitor systems, processes, and facilities;


• Represent and support the QA team during client and regulatory audits or inspections.


• Review batch records and manufacturing documents for product and process compliance;


• Review investigation reports for deviations, non-conformities, and customer complaints;


• Ensure products, processes, facilities and systems conform to quality standards and regulations, assisting in reviewing procedures, specifications, and forms.


• Evaluate and approve qualification protocols/reports and cleaning procedures for facilities and equipment;


• Ensure annual validation and qualification plans for infrastructures, equipment and processes are executed according to regulatory requirements.


• Support team members in daily tasks to maintain alignment with key objectives;


• Communicate actively across departments to identify continuous improvement opportunities;


• Promote QA best practices and foster a quality-oriented culture throughout the company.

requisitos/requirements

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology,Pharmaceutical Sciences, or related fields;


• Typically requires 5 years of relevant experience within a Quality AssuranceGMP environment within the Pharmaceutical Industry (mandatory);


• Solid knowledge of Quality, GMPs, ICH and ISO guidelines, principles andpractices;


• Good communication skills (verbal and written);


• Skilled at managing processes and tools;


• Fluency in English;


• Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down;


• Strong team player with a collaborative mindset, highly empathetic and a natural willingness to share knowledge and insights;


• A proactive attitude toward continuousimprovement of QA processes, with the resilience to manage complexsituations and turn them into learning opportunities.

oferta/offer

• Competitive salary package tailored to market standards and individual experience;


• Opportunity to work in a high-impact, cutting-edge industry (Cell & Gene Therapy / Biologics);


• Dynamic, collaborative, and scientifically rigorous environment with continuous learning and career advancement opportunities.

Randstad is on a mission to become the world’s most equitable and specialized talent company; therefore, we welcome individuals with diverse abilities and experiences. We are committed to ensuring that our recruitment and hiring process meets everyone's needs.

If you require any accommodations to make your application or interview more comfortable, please do not hesitate to let our recruitment consultants know.