(Senior) Manager Quality Operations & GDP Deputy RP job in Aubonne, France

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Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Good Distribution Practice (GDP)

Location: France

This vacancy has now expired. Please see similar roles below...

Proclinical are partnering with a biotech organisation who are currently recruiting for an individual to join their team. This role is on a contract basis and is located in wither Switzerland or France. The opening position available is for a (Senior) Manager Quality Operations & GDP Deputy RP.

Responsibilities:

Supervise quality systems for trends and give notice to management of events needing immediate action.
Handle events, changes, CAPAs mediating with the pertinent functions of the business unit, production units and suppliers.
Assist with the tech transfer, such as DS and SP for biosimilars, as well as analytical method transfer and offer quality oversight for GMP compliant implementation.
Offer quality assistance guaranteeing smooth transition from development to commercial.
Gather key quality/compliance indicators for periodic evaluation of local quality management systems.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a technical, engineering or similar discipline.
Demonstrable experience within a quality function with increasing levels of accountability within a biotech, life science or pharmaceutical organisation.
Comprehension of quality standards, for example: ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10, etc., cGMP & GDP needs for Pharmaceuticals and Combination Products, which involves Biologic Products.
Comprehension of GMPs and best quality practices concerning biotech manufacturing procedures.
Familiarity with regulatory agencies, for example: FDA, EMA, etc.
Exhibited background within third-party's quality management.

If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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Salary

Highly Competitive

Location:

Paris, France

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