IT-QA Analyst (m/f/d)

Tentamus Group GmbH; Berlin; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A global product and safety firm is looking for an IT Quality Assurance Analyst (m/f/d) in Berlin. You will support teams with quality procedures and compliance, involving training and overseeing validation activities. The ideal candidate has a degree in a relevant field and experience in IT QA. The role offers hybrid work options and long-term career prospects in a supportive environment.

Leistungen

Permanent employment contract

Flexible working hours

Individual training offers

Corporate Benefits

Qualifikationen

• At least 3 years of professional experience in an IT Quality Assurance role.
• Written and oral fluency in English and German (Level C1) required.
• GMP experience is a plus.

Aufgaben

• Develop and implement quality standards including SOPs for IT products and services.
• Manage trends in operational compliance risks and issues.
• Participate in audits and inspections to find solutions for compliance gaps.

Kenntnisse

IT Quality Assurance

Analytical skills

Communication skills

Problem-solving abilities

Knowledge of cGMP regulations

Proficiency in Quality Management software

Collaboration

Knowledge of LIMS validation

Ausbildung

Bachelor’s or master’s degree in computer science, Pharmacy, Engineering

Jobbeschreibung

Why us?

Our Company

Tentamus Group is a global product and safety firm with a core presence in Europe, UK, Israel, Asia and North America. We test and consult on products involving the human body with strong focus on food, pharmaceuticals, nutritional supplements, medical devices and cosmetics. With our Headquarters in Berlin, Tentamus is represented in 100 locations across 23 countries, with just under 4,000 highly trained staff members.

Required skills and qualifications

• Bachelor’s or master’s degree in computer science, Pharmacy, Engineering
• At least 3 years of professional experience in an IT Quality Assurance role.
• Proficiency in handling IT QA SOPs, implementing Quality Policies, providing Trainings to the Users within the IT and Tentamus Laboratories.
• GMP experience is a plus.
• Good communication skills as a collaborative team player in cross-cultural and cross-functional environments.
• In-depth knowledge of cGMP regulations and IT Quality Assurance practices.
• Strong organizational and documentation skills.
• Excellent analytical and problem-solving abilities.
• Proficiency in using Quality Management software and tools.
• Ability to work collaboratively with cross-functional teams.
• Knowledge of LIMS validation and roll out of LIMS to different laboratories
• Written and oral fluency in English, German (Level C1)

Travel
Travel is expected and may occasionally occur for educational/career development purposes.

Important note: Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, application without a valid work permit may not be considered.

Your contact

Tentamus Group GmbH
Human Resources
M: [phone]
If you have any questions about the application process, please do not hesitate to contact us. We are always happy to answer your questions.

Summary/Objective

Job Title:IT-QA Analyst (m/f/d)
Reports to:TBD
Supervisory Responsibilities:Yes
Department:IT
Primary Location:Berlin, Hybrid work
FLSA Classification:Full-Time

Our laboratory is currently looking to fill a full-time position for an IT Quality Assurance Analyst (m/f/d). As a team member, you will be responsible for establishing the Quality Culture within the IT department. You are going to support our teams by providing training on the Quality Procedures established in the company. Overseeing/ Approving the validation activities. Help us to stay up to date with IT Regulations in GMP and non-GMP industry. This role will collaborate cross-functionally with IT, QA and CSV teams. You are driven by improvement and are aiming for success thinking in a bigger picture for business.

We Offer

• Challenging tasks, a motivated team, and long-term prospects in a healthy owner-managed family business
• Permanent employment contract with long-term career prospects
• Flexible working hours and hybrid options, supporting a strong work-life balance
• A motivated team, flat hierarchies, and a very family-friendly working environment
• Individual training offers (Tentamus Academy) and the opportunity to help shape the growth of a medium-sized company
• Joint team events and leisure opportunities
• Corporate Benefits

Primary Responsibilities

• Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections and provide compliance for IT activities.
• Development and implementation of quality standards including SOPs and processes for IT products and services
• Assessment of the Regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes review of major/critical observations from other Tentamus sites and implementation of CAPA as appropriate. Requirement for sites to remain inspection ready at all times.
• Identify, communicate, and manage trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders
• Preparation, review and approval of validation deliverables so knowledge of Computerized Software Validation
• Provide compliance input to prepare for internal management reviews, and external regulatory and internal inspections as required.
• Drive continuous monitoring, improvement, and digitalization of our processes, services, and tools, through applying LEAN thinking and techniques, and exploiting tools and automation.
• Utilize your compliance experience to provide directions to program/project/service managers and system owners, in developing a risk-based approach for the delivery of compliant IT solutions.