QA Validation Manager Job in Beerse, Belgium

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:
The world’s sixth-largest consumer health company
The world’s largest and most diverse medical devices and diagnostics company
The world’s fifth-largest biologics company
And the world’s eighth-largest pharmaceuticals company
We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

QA Validation Manager Job Description

Within the Quality Department of the Janssen Supply Chain Organization, the Qualification and Validation Team is responsible for qualification of production and lab equipment and validation of computer validation systems, cleaning recipes and manufacturing processes in the PDMS and JSC organizations.

The mission of the organization is to ensure that the validation and qualification is executed and documented according to the current quality and compliance standards based on the critical quality attributes and process parameters in order to meet the specifications with acceptable degree of confidence and also meets business requirements.

To support the professional deployment of these Qualification and Validation activities throughout the Supply Chain organization of Beerse, Janssen is looking for a new

QA Validation Manager Process-, Cleaning- & Sterilization Validation

As validation manager you will be responsible for a team of validation engineers and will be responsible for process and cleaning validation and optimization, sterile process validation and technology transfer to further maintain and strengthen the support to production and ensure compliance to the international regulations and guidelines.


Your Responsibilities:

• You are responsible for maintaining the process validation status of pharmaceutical products in the commercial manufacturing area (JSC) .
• You are responsible for maintaining the cleaning validation status of equipment used in the commercial manufacturing area (JSC) and the clinical manufacturing area (PDMS).
• You are responsible for maintaining the validation status of sterile processes (parenteral production, aseptic processing) in in the commercial manufacturing area (JSC) and the clinical manufacturing area (PDMS).
• You act as responsible sterility engineer.
• You are part of technology transfer teams and interact with other groups for the introduction of new products, new systems and processes. You give advice and support for the preparation of validation related activities and guard the cGMP aspects in new projects. You are a member of cross-functional teams to realize cross-departmental objectives.
• You act as Subject Matter Expert for validation related topics for change control and deviation handling.
• You maintain a current knowledge of international regulations, guidelines and new evolutions related to validation topics through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve validation standards at Janssen.
• You issue, review and approve validation documents such as validation plans, protocols, reports, master documents, rationales, statements, SOPs, cleaning recipes,... in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• You prepare for regulatory and customer audits and inspections and you are the spokesperson for validation related matters during audits and inspections.
• You are responsible for leading and coaching the validation team existing of internal and external validation engineers and evaluate and manage the performance of the validation group periodically
• You are responsible to manage the resources and budget for the validation department and for selecting and hiring validation engineers if needed
• You are responsible to stimulate innovative behavior of the employees.
   

QA Validation Manager Job Requirements

What does Johnson & Johnson require of a QA Validation Manager:

• You have an Engineering, Pharmacy, or equivalent degree
• Master degree in technical/chemical area or similar.
• A 5 plus years of comprehensive experience with validation and sterile processes in pharmaceutical area is required.
• You have a profound knowledge of validation of typical sterile processes (sterilization, depyrogenisation, isolator decontamination, gamma irradiation, filter validation,…)
• Strong working experience in regulatory controlled environment: 21 CFR Parts 210, 211; EU Directive 2003/94/EC and annexes is also required.
• You are capable of leading cross-functional teams and motivating people and you have good communication, organization and planning skills
• You have demonstrated experience in writing and managing compliance documentation.
• You have excellent verbal and written communication skills. You are fluent in  English (written and spoken).
• You possess the credibility and experience to act as subject matter expert during internal audits and external regulatory inspections.
• Experience and understanding of audit readiness and management is required.
• You have a demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks and are able to able to correctly estimate the urgency, criticality and impact of decisions related to the function
• You have strong influencing , collaboration and negotiation skills.
• You are able to able to correctly estimate the urgency, criticality and impact of decisions related to the function

QA Validation Manager Application Information

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QA Validation Manager Summary

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