CQV Consultant (h/f/d)

Akkodis • Teilzeit/Vollzeit • Zürich, Zürich, Schweiz • vor 1 Wo.

Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC.

Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines - Consulting, Solutions, Talents and Academy - to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow. Akkodis is part of the Adecco Group.

We are seeking an experienced CQV Consultant to join our team in the life sciences sector.

The role involves overseeing the commissioning, qualification, and validation processes of equipment, systems, and facilities in pharmaceutical, biotechnology, and medical device environments.

You will ensure that all systems and processes meet regulatory requirements and are in compliance with Good Manufacturing Practices (GMP) and other industry standards.

The consultant will work closely with cross-functional teams to guarantee that systems are tested, verified, and validated for production readiness.

Commissioning

Plan and execute commissioning activities for new equipment, systems, and facilities.
Ensure systems and equipment are installed and functioning according to design specifications.
Develop and review commissioning documentation, including functional specifications and test protocols.

Qualification (IQ/OQ/PQ)

Lead and execute qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment and systems.
Develop and execute validation protocols, ensuring systems meet industry and regulatory requirements.
Document all qualification efforts, maintaining thorough and accurate records.

Validation

Develop, review, and execute validation strategies for processes, equipment, and software systems in compliance with GMP regulations.
Conduct risk assessments to identify critical process parameters and ensure systems are capable of producing consistent results.
Collaborate with project teams to ensure that validation activities are aligned with project timelines and objectives.
Regulatory Compliance
Ensure all commissioning, qualification, and validation activities comply with FDA, EMA, and other global regulatory bodies.
Provide guidance on industry best practices and regulatory changes impacting validation processes.
Prepare validation summary reports and present findings to regulatory authorities during inspections or audits.

Continuous Improvement

Identify areas for improvement in commissioning, qualification, and validation processes.
Recommend solutions to enhance compliance, efficiency, and quality in system validation and commissioning.

Company details

Global healthcare company focuses on innovative medicines, using advanced science and technology.
Candidate's Profile

Required Skills and experience.

Familiarity with CSV (Computer Systems Validation) processes.
Certification in validation (e.g., ISPE).
Experience with automated systems and data integrity considerations in validation processes.

Qualifications

Bachelor's or master's degree in engineering, Life Sciences, or related field.
3+ years of experience in commissioning, qualification, and validation within the life sciences industry (pharmaceuticals, biotech, or medical devices).
Strong understanding of GMP, FDA, EMA, and ISO standards.
Experience with risk-based validation approaches and regulatory compliance.
Proficiency in developing and executing IQ, OQ, PQ protocols.
Excellent problem-solving skills, attention to detail, and organizational abilities.
Strong communication skills, both written and verbal.
Ability to work effectively with cross-functional teams and manage multiple projects simultaneously.

Akkodis

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