Overview
QA Engineer Jobs in Visp, Valais, Switzerland at Capgemini Engineering
Title: QA Engineer
Company: Capgemini Engineering
Location: Visp, Valais, Switzerland
Follow your passion in a role where you will be exposed to the technologies and processes that leading global companies utilize, and join our innovative team as,
QA Engineer
Responsabilities:
QA Oversight of CQV Activities: Provide comprehensive quality assurance oversight for commissioning, qualification, and validation activities, ensuring adherence to regulatory guidelines and company standards.
Document Control and Approval: Review and approve all CQV documentation, including protocols (IQ, OQ, PQ), validation reports, test scripts, Standard Operating Procedures (SOPs), and validation master plans, ensuring accuracy and compliance.
Approval of Qualification Protocols & Execution Reports: Assess and approve qualification protocols and execution reports, ensuring that all test results and deviations are properly documented and compliant with regulatory expectations.
Quality Risk Management: Conduct quality-focused risk assessments and collaborate with teams to develop and implement mitigation strategies to address identified risks in CQV activities.
Compliance Audits: Actively participate in audits by internal and external regulatory bodies, providing QA support for CQV documentation and addressing any audit findings.
Change Control Management: Evaluate and approve changes to qualified systems, equipment, and processes, ensuring ongoing compliance with validation requirements.
Investigations and CAPAs: Lead investigations into quality-related issues identified during CQV activities and ensure the timely implementation of Corrective and Preventive Actions (CAPAs).
Continuous Improvement: Identify and implement improvements in QA processes related to CQV to enhance efficiency, compliance, and overall quality.
Requirements:
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
5+ years of experience in QA roles with a strong focus on CQV activities within the pharmaceutical or biotechnology industry.
Proven experience in reviewing, approving, and writing qualification protocols (IQ, OQ, PQ) and execution reports.
In-depth knowledge of CQV processes, including IQ, OQ, and PQ, as well as associated regulatory requirements.
Familiarity with cGMP, FDA, EMA, and ICH guidelines, with proven experience in ensuring compliance.
Strong analytical and problem-solving skills, with a focus on quality and compliance.
Proficiency in technical writing for quality documentation and regulatory submissions.
Strong interpersonal and communication skills to work effectively with cross-functional teams.
Ability to prioritize and manage multiple tasks in a fast-paced environment.
Fluency in English
If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.
Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.
Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting.
A multi-stage model with career opportunities through specialization prospects with over 250’000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
