Vacature Deviation Lead, GMP Specialist

Deviation Lead, GMP specialist

• R&D
• Clinical Supplies
• Leiden, South Holland, Netherlands
• 8 04 2023
• ID 23W

The Clinical Manufacturing team in Janssen Leiden is hiring!!

The operations department plays a central role within BU3 clinical manufacturing team and is responsible for on time manufacturing and delivery of the planned NPI and Resupply within the year. High quality is a ground rule for delivering safe product to the patient.

The GMP&Compliance team is responsible for the general GMP&Compliance related items for the clinical area and supports the production team with specialized and in-depth knowledge and skills on the GMP processes and systems (Quality Investigations, Continuous GMP improvements, training creation etc…)

The GMP team is looking for a motivated and high skills team member who would like to support the production team with KPIs, in particular Non-conformances, CPAs and corrections.

Essential Job Duties and Responsibilities include, but are not limited to, the following:

As a GMP specialist - Deviations Lead - you will be responsible for leading the deviation investigations of any deviation that occurs in the clinical manufacturing facility. You will be responsible for the opening and closing the loop while investigating, including Product Impact Assessments, Root Cause Analysis, and Corrective Actions. You are responsible to follow up the RCA (root cause analysis) and making sure that the progress is documented in a compliant way. Additionally, you will also work on maintenance and improvement of general GMP processes, if needed. Examples are support in emergency Change Controls, Training, updating general GMP procedures, support in inspections etc.

ou collaborate closely with the operations department, the equipment owners and the process engineers and other staff members of the API CM department. Also, you are a key contact for and work closely with the Quality Department.

General Activities:

· Lead deviation investigations and documenting product impact analysis and root cause investigation, including CAPA records

· Develop adequate measures to show effectiveness of the corrections and CPAs.

· Develop / implement the tools needed to ensure that deviations are executed in a compliant cGMP manner.

· Responsible for follow up, and ensuring compliant documentation and timely completion;

· Ensuring that relevant corrections and/or improvements on production processes and systems are made within the API CM team;

· Monitor progress and KPI for this process

General scope of responsibilities:

· Support in keeping general API CM GMP documentation up-to-date;

· Support of documentation periodic review within API CM department;

· Support internal batch release process.

· Be familiar with daily activities in Manufacturing

· Facilitate an environment of continuous improvement

· Facilitate an environment of open communication

· Lead investigations in work area as necessary.

· Ability to work independently and as part of a team

· Previous experience as a deviation lead in a cGMP environment is required

Desirable:

· Manufacturing experience within a GMP regulated environment.

· Min 2-5 years relevant work experience in a biotechnology or biopharmaceutical industry environment. Technical background (TU) is also okay.

· Familiarity with learning management and tracking systems

· Analytical ability and dealing with complexity

· Flexible, can deal with changing priorities, and stress-resistant.

· Innovative: Continuous innovation of the work processes and working environment.

Key competencies required:

• Excellent interpersonal skills.
• Proactive
• Ability to operate as part of a team is critical.
• Customer focus.
• Innovative.
• Mechanical/Technical aptitude.
• Excellent communication skills both written and verbal.
• Attention to detail.
• Good problem-solving skills.
• Results and performance driven.
• Adaptable and flexible.
• Positive attitude

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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. Equal Employment Opportunity Posters

Functie:	deviation lead gmp specialist
Startdatum:	12-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.