PDS QA Project Specialist
Thermo Fisher Scientific
PDS QA Project Specialist
Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionReporting to the assigned QA Operations Team Leader, the PDS QA Project Specialist supports the Qualified Person (QP) in the evaluation and certification of manufactured batches and the manufacturing environment by reviewing Certificates of Analysis and all supporting quality documentation. The role performs preliminary impact assessments of deviation events, reviews investigation reports, manages customer complaints, and reviews investigation records in compliance with company standards, internal procedures, and applicable regulations (GMP, FDA, and other relevant requirements).RESPONSIBILITIESBatch Release SupportSupport the Qualified Person (QP) and the Quality Operations Manager in batch release activities by ensuring compliance with product specificationsEnsure proper filing and archiving of all Batch Record documentation in accordance with company procedures and quality standards.Investigation Record ReviewPerform preliminary assessments of deviations and customer complaints, assign the initial criticality level, and evaluate the need for escalation to management.Review investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs).Perform comprehensive reviews of deviation and complaint investigations, including:supporting investigation documentation; quality impact assessment on affected batches and manufacturing areas; regulatory and compliance impact assessments.Contribute to achieving departmental Zero Past Due objectives as well as Right First Time (RFT) and On-Time Delivery (OTD) targets.Approve CAPAs and evaluate effectiveness verification.Customer Management & InspectionsParticipate in periodic customer meetings and provide quality support by responding to customer inquiries related to the assigned area of responsibility.Notify customers of deviations and complaints in accordance with the applicable Quality Technical Agreement (QTA) and ensure timely closure of records in TrackWise.Prepare customer-specific KPIs and participate in customer site visits.Actively participate in audit preparation activities.Support the presentation of quality topics during customer and regulatory audits.ComplianceEnsure completion of all assigned training activities.Maintain and continuously update Standard Operating Procedures (SOPs) related to the assigned area by preparing the necessary documentation in compliance with current GMP requirements.Review Master Batch Records (MBRs) related to PDS projects (clinical and commercial batches).Review Change Controls related to PDS projects.Review protocols and reports associated with clinical batches.Prepare Product Summary Files (PSFs) for clinical batches in accordance with current SOPs and ensure they remain up to date.Prepare Risk Assessments related to PDS projects within the assigned area of responsibility.Review Failure Mode and Effects Analyses (FMEAs) related to PDS projects.KEY INTERFACESInternalManufacturingQA Compliance & Regulatory / Quality ControlBusiness Managers & PMOTechnical ServicesLogisticsExternalCustomersRegulatory AuthoritiesREQUIREMENTSExperience in pharmaceutical quality assurance or related GMP environmentBachelor's Degree (or equivalent) in: Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology or another relevant scientific disciplineFluent English communication skills, both written and spokenComprehensive knowledge of GMP regulations, FDA guidelines and quality systemsExperience in deviation investigations and CAPA managementStrong understanding of aseptic manufacturing processes and controlsKnowledge of root cause analysis and quality improvement tools
Locations
- Italy, Monza
Skills Required
- pharmaceutical quality assuranceintermediate
- GMP regulationsintermediate
- deviation investigationsintermediate
- root cause analysisintermediate
Required Qualifications
- Experience in pharmaceutical quality assurance or related GMP environment (experience)
- Bachelor's Degree (or equivalent) in: Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology or another relevant scientific discipline (degree in equivalent)
- Fluent English communication skills, both written and spoken (experience)
- Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems (experience)
- Experience in deviation investigations and CAPA management (experience)
- Strong understanding of aseptic manufacturing processes and controls (experience)
- Knowledge of root cause analysis and quality improvement tools (experience)
- Experience in pharmaceutical quality assurance or related GMP environment (experience)
- Bachelor's Degree (or equivalent) in: Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology or another relevant scientific discipline (degree in equivalent)
- Fluent English communication skills, both written and spoken (experience)
- Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems (experience)
- Experience in deviation investigations and CAPA management (experience)
- Strong understanding of aseptic manufacturing processes and controls (experience)
- Knowledge of root cause analysis and quality improvement tools (experience)
Responsibilities
- Batch Release Support
- Support the Qualified Person (QP) and the Quality Operations Manager in batch release activities by ensuring compliance with product specifications
- Ensure proper filing and archiving of all Batch Record documentation in accordance with company procedures and quality standards.
- Support the Qualified Person (QP) and the Quality Operations Manager in batch release activities by ensuring compliance with product specifications
- Ensure proper filing and archiving of all Batch Record documentation in accordance with company procedures and quality standards.
- Investigation Record Review
- Perform preliminary assessments of deviations and customer complaints, assign the initial criticality level, and evaluate the need for escalation to management.
- Review investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs).
- Perform comprehensive reviews of deviation and complaint investigations, including:supporting investigation documentation; quality impact assessment on affected batches and manufacturing areas; regulatory and compliance impact assessments.
- Contribute to achieving departmental Zero Past Due objectives as well as Right First Time (RFT) and On-Time Delivery (OTD) targets.
- Approve CAPAs and evaluate effectiveness verification.
- Perform preliminary assessments of deviations and customer complaints, assign the initial criticality level, and evaluate the need for escalation to management.
- Review investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs).
- Perform comprehensive reviews of deviation and complaint investigations, including:supporting investigation documentation; quality impact assessment on affected batches and manufacturing areas; regulatory and compliance impact assessments.
- Contribute to achieving departmental Zero Past Due objectives as well as Right First Time (RFT) and On-Time Delivery (OTD) targets.
- Approve CAPAs and evaluate effectiveness verification.
- Customer Management & Inspections
- Participate in periodic customer meetings and provide quality support by responding to customer inquiries related to the assigned area of responsibility.
- Notify customers of deviations and complaints in accordance with the applicable Quality Technical Agreement (QTA) and ensure timely closure of records in TrackWise.
- Prepare customer-specific KPIs and participate in customer site visits.
- Actively participate in audit preparation activities.
- Support the presentation of quality topics during customer and regulatory audits.
- Participate in periodic customer meetings and provide quality support by responding to customer inquiries related to the assigned area of responsibility.
- Notify customers of deviations and complaints in accordance with the applicable Quality Technical Agreement (QTA) and ensure timely closure of records in TrackWise.
- Prepare customer-specific KPIs and participate in customer site visits.
- Actively participate in audit preparation activities.
- Support the presentation of quality topics during customer and regulatory audits.
- Ensure completion of all assigned training activities.
- Maintain and continuously update Standard Operating Procedures (SOPs) related to the assigned area by preparing the necessary documentation in compliance with current GMP requirements.
- Review Master Batch Records (MBRs) related to PDS projects (clinical and commercial batches).
- Review Change Controls related to PDS projects.
- Review protocols and reports associated with clinical batches.
- Prepare Product Summary Files (PSFs) for clinical batches in accordance with current SOPs and ensure they remain up to date.
- Prepare Risk Assessments related to PDS projects within the assigned area of responsibility.
- Review Failure Mode and Effects Analyses (FMEAs) related to PDS projects.
- Ensure completion of all assigned training activities.
- Maintain and continuously update Standard Operating Procedures (SOPs) related to the assigned area by preparing the necessary documentation in compliance with current GMP requirements.
- Review Master Batch Records (MBRs) related to PDS projects (clinical and commercial batches).
- Review Change Controls related to PDS projects.
- Review protocols and reports associated with clinical batches.
- Prepare Product Summary Files (PSFs) for clinical batches in accordance with current SOPs and ensure they remain up to date.
- Prepare Risk Assessments related to PDS projects within the assigned area of responsibility.
- Review Failure Mode and Effects Analyses (FMEAs) related to PDS projects.
- Manufacturing
- QA Compliance & Regulatory / Quality Control
- Business Managers & PMO
- Technical Services
- Logistics
- QA Compliance & Regulatory / Quality Control
- Business Managers & PMO
- Technical Services
- Customers
- Regulatory Authorities
- Regulatory Authorities
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