QA Officer, Boxmeer
QA Officer, Boxmeer
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5830 Boxmeer, Nederland
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Geplaatst op: gisteren
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Onthouden
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr
Belangrijke informatie
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BedrijfsnaamSIRE LIFE SCIENCES
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PositieQA Officer
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Meer informatie over deze advertentie
QA Officer is geplaatst in de Boxmeer overige banen rubriek op Locanto.
Op dit moment is dit de enige advertentie in deze rubriek onder Boxmeer.
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