Quality Assurance Manager - GMP/ISO, Biotech CDMO

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

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.