Corporate Quality Assurance manager (1)

Výzkum a vývoj a výroba léčivých přípravků Carrer de Castelló, 1, 08830 Sant Boi de Llobregat Barcelona, Španělsko
We are currently seeking a full-time Corporate QA Manager with specialized expertise in computer system validations to ensure compliance for our corporate systems. The role entails providing support to Synthon organization and affiliates on projects and quality issues from a QA perspective.

Additionally, the Corporate QA Manager will be involved in the maintenance and improvement of Synthon's pharmaceutical quality systems, promoting continuous improvement of the quality systems and ensuring proper implementation of new guidelines and regulations. The position will report to the Director of Corporate Quality Assurance at our affiliate in Spain.

You will report to the Director Corporate Quality Assurance, located at our affiliate in Spain.
Job details
The Corporate Quality Assurance manager must ensure the proper qualification of corporate GXP computerized systems (such as IsoTrain, SRT, Argus, TrackWise, and MyQumas) in close collaboration with the Corporate Information Services department. The incumbent must also adopt a QA approach for computer system validation, which includes reviewing and approving protocols and reports, performing risk assessments, and conducting routine evaluations.

Providing exceptional advisory services to all affiliates and departments on computer system validation topics is also a critical aspect of the role. The position holder will be responsible for keeping the QA administration of corporate quality systems and documentation software current, including upgrades, writing and maintaining the quality manual, policies, and corporate procedures/work instructions.

Job details

You would be required to:
Management of change controls, deviations, audits and CAPAs through corporate quality management system
Support on implementation of new regulations/systems
Participating in the definition and execution of the projects to achieve the objectives of the department
Participating on behalf of QA in the setup of global developments when requested.
Your profile

Your qualifications are:
HBO/Bachelor degree or demonstrated level of experience and education on computer system validation field.
Minimum of 2 years of work experience in the pharmaceutical, biopharmaceutical or medical device industry, e.g. QA, QC, production, IT or development
Proven in-depth knowledge of laboratory informatics systems like LIMS and ELN
Knowledge of quality assurance, compliance and validation of computerized systems in the scope of pharmaceutical industry
Knowledge of the regulatory requirements of the recognizing regulatory authorities to enable assessment of the applicability and compliance with such laws, regulations, and standards.

English both in writing and in speaking.
Motivated, pragmatic and results-oriented.
Our offer
At Synthon, we provide our employees with a working environment that emphasizes trust, pride, and joy. This approach has earned us recognition as a Great Place to Work® in 2017 and 2019. As a company, we recognize our impact on the wider world, including the economic, social, and environmental aspects. Our values are rooted in caring for one another, our partners, patients, and society at large. We actively support various educational initiatives and contribute to charitable causes, as well as working to develop the communities to which we belong worldwide.

We offer our employees:
A professional, yet pleasant and informal working environment with short communication lines, focus on cooperation and appreciation of initiatives
Competitive remuneration
Good working conditions with attention to ergonomic support
A keen eye on work/life balance, with the option to partly work from home
A yearly outing with all colleagues and other inspiring company events.
Application
Apply now
If you are interested in this fulltime position and you would like to join our company, we look forward to your application. Please send your application before 20 May 2023. The first of interviews will take place 25 May and might consists of more rounds of interviews.

Contact
For further information, please contact Gert Klein Kranenbarg, vice president Quality Operations at tel. +31 (0)24 371 2544 and/or Merche López, Director Corporate Quality Assurance (ES) at tel. (+34) 93 640 15 16.

How to apply
Application procedure
Grow in your career and make a difference. As a global company, we offer a wide range of career opportunities. Find a challenging and fulfilling job at Synthon.

1
Apply with Synthon
We will review your application and check if you are a good fit for the role and the company.
2
Let’s meet
Our team will arrange a meeting for the role you’ve applied for, if you meet our requirements.
3
Review
Our HR team and the manager will review the results of the interviews, tests and reference checks, and make a final decision on who to hire for the position.

4
Offer
Once a candidate has been selected, an offer letter will be sent out outlining the terms and conditions of the position, salary and benefits.
5
Start your new job
Welcome to Synthon! Congratulations, you are ready to begin your new job.
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