Supplier Validation Engineer, German, GMP, 21 CFR 820, 21CFR 11

Solothurn  ‐ Vor Ort
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Supplier Validation Engineer, German, GMP, 21 CFR 820, 21 CFR 11

I have an excellent opportunity to work for the worlds largest life-science company and within the worlds largest medical device quality remediation project which has been the result of an FDA 483 warning letter.

The contract is an initial 3 months, however due to the huge nature of the project, this contract could be extended to the end of December 2015!

I require a fluent German and English speaker for this role.

Job description:

Supplier Validation Engineer:
To provide support for the validation activities associated with special processes at suppliers (mainly located in Switzerland and south of Germany), equipment, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of the end client Validation Policies and Procedures are addressed.

Primary Tasks and Responsibilities:
-Serves as technical expert for the Validation process and responsibilities to ensure compliance
-provide training and guidance to suppliers
-Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations at suppliers, as appropriate for each validation exercise
-Continuous Learning/Managing Risk
-Facilitates successful team behaviour within Supplier Quality, Quality Ops and across functional areas -Manages relationships externally (Suppliers) and internally.
-Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
-Ensure that all validation activities are carried out and reported in a timely manner.
-Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment

Knowledge of bespoke validation. Must: In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry, High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.

Profile Requirements:
Must be able to lead and give direction to Validation Projects and Teams. Must be able to train suppliers on the validation requirements. Individual must also be an active team member in Validation activities Methodology/Certification Requirements. Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science ) with a broad technical/educational skills base. Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.

Non Technical Skills and Additional Details:
Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.

Language proficiencies: - English and German spoken and written

ABOUT SENTINEL:

In a connected world, relationships matter. For over 15 years, our recruiters have been building networks that connect the very best technologists. No one is better placed to reach the people who can help you succeed. We can name some of the global top 10 life science companies as valued clients and what we offer goes beyond the normal scope of the client-agency-candidate relationship. With our head office in the UK and our new Swiss based office, your profile will be treated with due care and attention and matched to the best possible role. We offer advice on CV structuring, interview technique and a concierge service when finalizing your contract or permanent offer with assistance in regards to booking flights/hotels, salary simulations, advice on local culture/living expenses and information on your new employer.
We have placed Quality Engineer's, CAPA consultants, Product Development Engineers, Auditors, Regulatory Affairs professionals Validation Engineers and CSV consultants across Europe and have a strong understanding of the requirements of our clients highly FDA/EUMDD/PAL regulated environments.

Supplier Validation Engineer, German, GMP, 21 CFR 820, 21 CFR 11

Start
ab sofort
Dauer
3 months+
(Verlängerung möglich)
Von
Sentinel IT LLP
Eingestellt
02.10.2014
Projekt-ID:
784342
Vertragsart
Freiberuflich
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