Life sciences quality and compliance engineer Job at Sopra Steria (Machelen)

Life sciences Computer System Validation Engineer

As a quality and compliance expert, you will be responsible for ensuring that Gx...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Proven CSV experience in multiple projects or strong interest in CSV
Strong affinity with IT
Analytical and pragmatic thinking skills
Strong prioritization and planning skills
Strong sense of responsibility and accountability
A positive, solution-driven mindset
Excellent written and oral communication skills in Dutch and English
Basic knowledge of IT infrastructure qualification
A team player, but also able to work independently
Familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Ensure that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle
Stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO
Provide Quality & Compliance support during audits and inspections
Join a Sopra Steria validation service team
Ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP)

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

Young Professional Life Sciences

Sopra Steria offers tailored, end-to-end corporate technology and software solut...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Educational Background: A degree in Life Sciences, Engineering, Pharmacy, or a related field
Knowledge of Validation and Qualification: Basic understanding of validation and qualification processes in the pharmaceutical industry is a plus
Technical Skills: Familiarity with Good Manufacturing Practices (GMP), regulatory guidelines, and industry standards
Analytical Skills: Ability to analyze data, identify trends, and draw meaningful conclusions
Problem-Solving: Skill in quickly resolving technical issues
Flexibility: Ability to adapt to changing environments and handle multiple tasks simultaneously
Stress Management: Capable of maintaining composure and effectiveness under pressure
Professionalism: Demonstrates a high level of professionalism in all interactions and tasks
Social Skills: Strong interpersonal skills, able to build and maintain positive relationships with colleagues and clients
Communication Skills: Excellent verbal and written communication skills, able to convey complex information clearly and concisely

Job Responsibility

Audits are conducted regularly to keep our standards high while adhering to strict quality control guidelines.

What we offer

Mobility options (including a company car)
insurance coverage
meal vouchers
eco-cheques
continuous learning opportunities through the Sopra Steria Academy
the opportunity to connect with colleagues at team events.

Product Specialist

Product Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, preferably Biomedical Engineering, Life Sciences, or a related field
At least 3 years of experience as a Product Specialist or similar role in the medical device industry
Strong knowledge of the medical device sector, including regulatory requirements and compliance standards
Excellent communication and presentation skills, with the ability to convey technical knowledge to non-technical audiences
Analytical skills to assess market data and develop effective sales strategies
Willingness to travel frequently to meet clients and attend industry events
Fluency in English, both written and spoken

Job Responsibility

Build and maintain strong relationships with existing customers by planning and organizing regular visits to ensure continuous support and identify new sales opportunities
Develop new business opportunities and convert them into long-term partnerships, contributing to sales success
Provide technical support and clinical training to customers on the effective use of medical devices, ensuring a high level of customer satisfaction
Coordinate and organize hands-on demonstrations, presentations, and educational programs for healthcare professionals, representing the company at congresses and symposiums
Actively collaborate with internal departments, including R&D, marketing, and quality assurance, to ensure effective product strategy alignment

Senior Specialist, Quality Assurance

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Suppl...

Location

United States

Salary:

149651.00 - 168146.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of Quality Compliance experience
Master’s degree & 4 years of Quality Compliance experience
Bachelor’s degree & 6 years of Quality Compliance experience
Associate’s degree & 10 years of Quality Compliance experience
High school diploma / GED & 12 years of Quality Compliance experience
Bachelor’s degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management

Job Responsibility

Own and lead the SQM/GSQ inspection readiness processes
Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
Maintain and continuously improve inspection readiness processes
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Quality Assurance

Location

Ireland , Dublin

Salary:

Not provided

Executive Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or Life Science related discipline
2+ years of Quality Assurance experience in a Life Sciences environment
Manage internal ISO quality process
Understanding of principles of Validation and New Product Introduction
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Proven experience participating in or leading audits and inspections

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations
Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents
Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
Review of executed validation documents and reports
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records
ensuring scope of record is clear and implementation activities are robust and timely
Perform all activities in compliance with company safety standards and SOPs

Fulltime

CSA & Quality Compliance Expert

The CSA & Quality Compliance Expert will support compliance and validation proje...

Location

Italy , Milan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.)
At least 3-5 years of experience in CSA activities within Life Science
Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11
Experience with risk-based validation approaches and familiarity with software validation in GxP contexts
Ability to manage complex projects and effectively collaborate with clients across multiple industries
Excellent analytical, planning, and problem-solving skills
Proficiency in English, both written and spoken

Job Responsibility

Draft and review validation documentation in compliance with industry regulations
Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA, and Data Integrity solutions
Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR, and other relevant regulations
Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments
Collaborate with cross-functional teams, including IT, QA, and operations, to ensure compliance with standards and regulations
Provide support during client and regulatory audits (FDA, EMA, ISO, etc.), supplying evidence and required documentation
Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors

Fulltime

Quality & Compliance Specialist – Responsible Person (RP)

We are looking for an analytical and driven Quality & Compliance Specialist to a...

Location

Sweden , Helsingborg

Salary:

Not provided

Academic Work

Expiration Date

Until further notice

Requirements

University degree in Life Sciences, Engineering, or a related field required to meet the Swedish regulatory requirements for a Responsible Person (RP)
Proven track record in GDP (Good Distribution Practice) and Quality Assurance (QA) within the pharmaceutical industry
Experience working with KPI frameworks and the ability to perform "data storytelling" to visualize quality trends
Fluency in English is required
Proficiency in Swedish is a strong merit
Ability to exercise lateral leadership and collaborate effectively across a cross-functional network

Job Responsibility

Act as the primary point of contact for the Swedish Medical Products Agency (Läkemedelsverket)
Ensure compliance with GDP regulations and manage notifications regarding product shortages
Implement and maintain local processes for Change Control, Non-Conformances (NC), and CAPA
Drive continuous improvement to ensure the QMS remains effective and aligned with business objectives
Oversee storage and distribution activities, qualify critical GxP suppliers (e.g., 3PL partners), and establish technical Quality Agreements
Define quality requirements for local value-added services such as repacking and relabelling, and approve changes to product artwork
Plan and execute self-inspections (internal audits) and provide lead support during Health Authority inspections and external audits
Coordinate any product recall operations and ensure that customer complaints are investigated, trended, and mitigated effectively

What we offer

Possibility to work remote
Stora möjligheter att växa professionellt och knyta värdefulla kontakter för framtiden
Du får en konsultchef som stöttar dig under resans gång
Får ta del av olika förmåner, bl.a. möjlighet till kompetensutveckling i form av en grundläggande hållbarhetsutbildning

Fulltime

Manufacturing Scientist

The Manufacturing Engineering, Scientist will be responsible for representing Op...

Location

United States , Austin

Salary:

Not provided

Diasorin

Expiration Date

Until further notice

Requirements

Bachelor's Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering, Microbiology, Life Sciences, Biomechanical Engineering required
8+ Years reagent Operations experience in a relevant ISO 13485:2003 and/or FDA regulated setting. Required
5+ Years experience servicing reagent Operations with process improvement, and/or sustaining engineering, and/or design transfer in a Life Sciences, Chemistry, Biomechanical, or Medical Technology field. Required
1+ Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities required
Thorough knowledge of ISO 13485 and FDA Quality System requirements
Proficiency in Enterprise Resource Planning, including applied knowledge of engineering functionality and familiarity with Manufacturing Execution Systems
Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
Proven expertise in automation solutions for high complexity, high product mix, small/large run production environment with batch processing up to 2000 Liters

Job Responsibility

Represent Operation in design teams
fulfill design transfer responsibilities for new and on market product development, validation, and market release phases.
Lead and assist in sustaining engineering projects for improvement of manufacturing processes, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and Enterprise Resource Planning.
Lead and assist in design input and implementation oversight of infrastructure improvement projects.
Identify and drive opportunities for process innovations, improvement, and cost reductions.
Participate and drive development and implementation of process automation strategies and solutions.
Assume full ownership of sustaining support for on-market processes
Participate in product feasibility collaborations with R&D, as needed.
Lead and assist in engineering change control and document change control activities
participate in change control reviews.

What we offer

Receive a competitive salary and benefits package as you grow your career at Diasorin.

Fulltime

Life sciences quality and compliance engineer

Sopra Steria

Location:
Belgium , Machelen

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 25, 2025

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