Senior QA Associate 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.

Senior QA Associate Job Description

Within the Quality Department of the Janssen Supply Chain Organization, the Product Quality group is responsible for assuring that all products that are released to the market meet all critical quality attributes and are in compliance with the marketing authorization.

The mission of the organization is to ensure that all products are manufactured in accordance with the cGMPs using validated or qualified processes in order to assure compliance with the specifications. Throughout the end-to-end process of product realization, the product needs to fulfill all regulatory requirements and meet the expectations of our patients.

As senior QA associate you will be responsible for assuring that sterile products are released in conformance with the cGMPs and the applicable marketing authorizations. You will support the end-to-end process of product realization and ensure compliance to the international regulations and guidelines.

Your Responsibilities:

• You are responsible for the handling of events with regard to the sterile manufacturing units. You assess the impact of critical and non critical events and you reach out to other groups if needed (GTS, engineering, stability,….) for support during the investigation.
• You are responsible for batch release for some identified products. You track regulatory approval and compliance with GMPs and manufacturing authorization before releasing product. You are in close contact with the QP with regard to any issues that would arise during the release process.
• In consultation with the relevant departments you define corrective and preventive actions after which you follow up on implementation and you monitor effectiveness of the actions.
• You perform internal audits as per schedule.
• You maintain a current knowledge of international regulations, guidelines and new evolutions related to the different quality process through self learning, literature studies, internal and external benchmarking and courses/conferences. You implement this knowledge to maintain and improve the quality processes at Janssen.
• You review and approve validation documents such as 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 the related products during audits and inspections.

Senior QA Associate Job Requirements

What does Johnson & Johnson require of a Senior QA Associate:

• You have a Pharmacy, Engineering, or equivalent degree
• A 5 plus years of comprehensive experience with microbiology, sterile process technology, cleanroom facilities and/or aseptic processing is required.
• You have a profound knowledge 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

Senior QA Associate Application Information

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Senior QA Associate Summary

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