Nederland

QA Officer, Boxmeer

QA Officer, Boxmeer
Advertentietekst
The Company A large scale pharmaceutical and life sciences manufacturing environment focused on high quality biological and chemical production. The organisation operates under strict GMP standards and supports continuous improvement across complex production operations.

About the Role The QA Officer plays a key role within Quality Operations, ensuring that all production activities comply with cGMP requirements. The role supports manufacturing from receipt through to distribution and acts as a quality partner to production teams. You will work closely with Qualified Persons and operational stakeholders to safeguard product quality and compliance.

Responsibilities

Advise on and approve equipment installation, qualification and validation protocols and reports as a subject matter expert

Support deviation investigations including root cause analysis, approval of studies, conclusions and CAPAs

Review and approve standard production documentation, protocols and master batch records for production and filling

Assess and approve process changes through change control procedures

Conduct routine audits of data, procedures, equipment, systems and facilities to ensure compliance with SOPs and GMPs

Review and approve production and analytical documentation for release of API, clinical supply or safety assessment lots

Communicate audit findings, resolve comments with stakeholders and issue reports summarising deficiencies

Support inspections and audits under supervision or as part of a team and elevate results to management

Requirements

At least HBO level education, preferably in Life Sciences, Pharmacy, Biology or Laboratory related studies

Experience in the pharmaceutical or chemical industry or within a drug regulatory agency

Hands on experience with biological and or pharmaceutical chemical production processes

Strong working knowledge of GMP and cGMP regulations

Excellent command of

Dutch

and English, both written and spoken

Strong communication and interpersonal skills

Ability to advise proactively and support change

Structured and detail oriented approach to quality compliance

Other Information

Possible 1 day from home after 6 months

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QA Officer is geplaatst in de Boxmeer overige banen rubriek op Locanto.

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