Whatis it like to work at SimoTech?
With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients.
In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
QAV Specialist ****
SimoTech has an opportunity for an experienced QAV Specialist tosupport a major brownfield expansion project within the Quality function of aleading life sciences facility.
This role is pivotal in ensuring that allquality, validation, and CSV activities are delivered in full compliance withcorporate procedures, regulatory expectations, and industry standards, whileenabling the successful execution of this high - value capital project.
The QAV Specialist will play a key rolein supporting the quality unit throughout the expansion project, reportingdirectly to the Quality Projects Lead within the Quality Department.
This is afully onsite role, with flexibility to work remotely on occasion depending onproject needs.
Key Responsibilities
Providelocal QA oversight for all Quality & Validation (Q&V) activitiesassociated with the project.
Reviewand approve QAV, QA, QC, CSV, and GMP-related documentation, ensuring alignmentwith site and global procedures as well as ISPE Verification guidelines.
Ensureall QA/QAV/QC deliverables are completed in line with project schedules andcompliance expectations.
Coordinateand manage the workload for the QA project stream, supporting project planning,tracking, and documentation readiness.
Participatein equipment, process, and design FMEAs, supporting risk identification andmitigation across systems.
ProvideCSV expertise, reviewing and approving lifecycle documentation including URS,risk assessments, test plans, validation/qualification protocols, and reports.
Identifyand communicate compliance requirements for facility, utility, equipment, andcomputerised systems within the manufacturing environment.
Actas a Quality SME, proactively identifying quality risks, proposing solutions,and facilitating cross-functional alignment across Manufacturing, Engineering,Utilities, QC, Validation, and global stakeholders.
Supportpreparation of project data, presentations, and participation in reviewmeetings.
Ensureconsistent interpretation and implementation of regulatory requirements, GMPstandards, and internal quality systems throughout the project.
Participatein regulatory and internal audits, ensuring robust evidence, documentationreadiness, and adherence to quality processes.
Maintainavailability for onsite collaboration as required in a hybrid, project-drivenenvironment, supporting fast-paced schedules and cross-functional meetings.
Requirements
Qualifications &Experience
Bachelor'sdegree in Life Sciences, Engineering, Computer Science, or related field.
Minimum3+ years' experience as a Quality SME supporting qualification/validationactivities in a regulated pharmaceutical environment.
Provenexperience contributing to or managing large capital projects, with strongplanning, decision - makingand self - managementskills.
Workingtechnical knowledge of engineering, utilities, QC, validation, andmanufacturing systems, enabling effective discussions with SMEs.
Experiencewith QRM, risk - based verification, ISPE Commissioning & Qualification guidance, GAMP 5, and risk - based decision making(desirable).
Experiencewith eValidation software (highly desirable)
Solidunderstanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrityprinciples.
Strongtechnical writing, communication, and stakeholder management skills.
Abilityto work independently and collaboratively in a fast-paced environment.
What SimoTech CanOffer
Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
Opportunity towork with large corporate clients
#J-*****-Ljbffr