IT-QA Analyst (m/f/d)

EPL Bio Analytical Services; Berlin; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A global product and safety firm in Berlin is seeking an IT Quality Assurance Analyst. This full-time role involves establishing a quality culture within the IT department, overseeing validation activities, and ensuring compliance with IT regulations. The ideal candidate has at least 3 years of experience, holds a relevant degree, and possesses strong communication skills. This position offers hybrid work options and long-term career prospects.

Leistungen

Challenging tasks

Flexible working hours

Individual training offers

Corporate Benefits

Qualifikationen

• At least 3 years of professional experience in IT Quality Assurance.
• GMP experience is a plus.
• Knowledge of LIMS validation and rollout.

Aufgaben

• Participate in audits and inspections for compliance.
• Development of quality standards for IT products.
• Drive continuous improvement and digitalization.

Kenntnisse

Proficiency in handling IT QA SOPs

Good communication skills

Strong organizational skills

Excellent analytical abilities

Fluency in English, German (Level C1)

Ausbildung

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

Tools

Quality Management software

Jobbeschreibung

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IT-QA Analyst (m/f/d)

Permanent employee, Full-time

• Berlin
  
  

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.

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.

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.
  
  

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.

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
  
  

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.

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About Us

Tentamus Group is a global product and safety firm with a core presence in Europe, UK, Israel, China and the USA. Tentamus tests and consults on products involving the human body with strong focus on food, nutraceuticals and cosmetics. Tentamus is represented in over 90 locations worldwide with more than 4,000 highly-trained staff members.

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