Qmip/Pqe (Sr. Project Quality Engineering)

Siemens Energy; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global engineering company in São Paulo is seeking a Specialist in External Quality Assurance to manage quality during processes in Brazil. The candidate must possess a Bachelor's degree in a relevant field and have 3-5 years of QA experience in the biopharmaceutical industry. Responsibilities include reviewing deviations, monitoring manufacturing activities, and collaborating with cross-functional teams. This position offers a challenging opportunity to ensure high-quality standards in a dynamic environment.

Qualificações

• 3-5 years of QA experience in the biopharmaceutical or cell/gene therapy industry.
• Experience with CDMO oversight, lot release, and deviation management.

Responsabilidades

• Review and approve deviations and OOS investigations.
• Monitor manufacturing campaigns and production activities.
• Ensure timely escalation and resolution of manufacturing and quality issues.
• Collaborate with cross-functional teams for regulatory filings.

Conhecimentos

Strong knowledge of cGMP

Excellent communication skills

Problem-solving skills

Formação académica

Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline

Descrição da oferta de emprego

Specialist – External Quality Assurance

Our 3 Core Values

Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting!

What You'll Do:

• Giving support for executing and ensuring quality during all processes in MSN Brazil.
• Maintain a standardized methodology that ensures the quality of processes of the product and company.
• Giving support to the involved areas on the execution of tests and internal certification of products to ensure quality standards and that proper functioning are met.
• Register and keep the information updated to avoid deviations in the defined quality parameters, agreeing preventive and corrective actions with the responsible for QA department.
• Maintain documents and plans updated (Incident, Notification, nomination, CAPAs, Deviation, Training, SOPs, etc), verifying the validity of registration, permits, among others.
• Support QA department responsible for Internal Audits, as part of the control and monitoring process.
• Monitoring of analytical quality assurance activities.
• Review and close the quality control log books.
• Review of instrument qualification documents and calibration records.
• Review of electronic data records.
• Review deviation investigation reports, OOT and OOS.
• Review specifications and test methods as appropriate.
• Responsible for opening/giving number of Incident, Notification, nomination, CAPAs.
• Supporting and ensures the continuity of the policies, processes and procedures of all compliance management systems.
• Carry out self-inspections together with the responsible for the QA department.
• Review of method validation, method verification and method transfer documents.
• Giving support on the analyses and action plan for the resolution of Non-Conformities.
• Responsible for preparing the documentation for new employees, ensuring training on the applicable SOPs.
• Review of batch audit trails.

Key Responsibilities

• Review and approve deviations, Out-of-Specification (OOS) investigations, CAPAs, and change controls from CDMOs and external testing laboratories.
• Monitor manufacturing campaigns, production activities, and resolve issues during routine manufacturing.
• Review and approve QC/analytical results and Certificates of Analysis from CDMOs/external labs.
• Review and approve production lot records for compliance prior to disposition.
• Perform GMP reviews of incoming documentation (batch records, test data, release packages).
• Ensure timely escalation and resolution of manufacturing and quality issues.
• Collaborate with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings.
• Support audit readiness activities for Regulatory Authority inspections.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline.
• 3-5 years of QA experience in the biopharmaceutical or cell/gene therapy industry.
• Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211.
• Experience with CDMO oversight, lot release, and deviation management.
• Excellent communication and problem‑solving skills.

Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical‑stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically‑optimized BCMA‑targeted chimeric antigen receptor T (CAR‑T) cell therapy NXC‑201 with a “digital filter” that filters out non‑specific activation.