Qualification and Cleaning Validation Specialist (limited) 100% - Fribourg

Employer
Vifor Pharma
Location
Villars-sur-Glâne, Switzerland
Salary
Competitive
Closing date
16 Oct 2020

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
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About You
We are looking for a Qualification and Cleaning Validation Specialist to support our team in Fribourg for a period of 18 months. At this position, you work within the Quality Assurance department in close collaboration with Manufacturing, Engineering and Laboratory to manage qualification and cleaning validation of existing equipment and new equipment. Your main activities are:
  • Design and develop cleaning procedures for new products and manufacturing equipment
  • Lead and perform risk assessments for determination of worst case, critical cleaning parameters and acceptance criteria
  • Review cleaning related method validations including specific and non-specific analytical methods and recovery studies as applicable
  • Develop technical and manufacturing documents (plans, protocols, reports) necessary for cleaning validation in alignment with corporate standards
  • Execute cleaning validation protocols (rinsing water, swabs, contact plates)
  • Provide technical support to cleaning activities associated with the manufacturing process
  • Performs successful and on time resolution of deviations related to cleaning exercises
  • Issue Change Controls required for the implementation of cleaning procedure changes
  • Train manufacturing and QC/QA personnel on cleaning documentation
  • Support the periodic review of equipment and cleaning validation methodologies
  • Review commissioning and qualification documents for utility, facility and process equipment (URS, FAT /SAT, IQ /OQ /PQ...)

For this challenge, we are searching for a dynamic, rigorous and social person bringing the following profile:
  • University degree in engineering or sciences area like chemistry, pharmacy, or similar
  • Minimum of 2 years of professional experiences in cleaning validation in the pharmaceutical industries
  • Previous experience in Equipment /Facility /Utilities Qualification in GMP environment
  • Fluent in French and good knowledge in English

You are a pragmatic person who likes to identify and solve problems from the roots. Responsible and methodical, you enjoy taking initiatives and demonstrate a rigorous approach to document and file management, with high attention to details. You have excellent organizational skills and prioritize according to needs. You are an open communicator with good interpersonal skills, who is able to build good working relationships with colleagues.

About Us
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit www.viforpharma.com/career

We are looking for new people to join an international team of more than 2,700 talented people, operating in over 100 countries to support our Vision of becoming global leader in our three therapeutic areas:

IRON DEFICIENCY

 

NEPHROLOGY

 

CARDIO-RENAL

 

WHY VIFOR PHARMA

We are a global leading expert in iron deficiency and iron deficiency anaemia.

We are proud of a broad portfolio to help nephrology patients suffering from kidney disease.

Our expertise in both these areas are helping cardio-renal patients.

We innovate internally, but we also partner with the best companies externally. We are also a unique pharmaceutical company, as we have direct access to Fresenius Medical Care clinics via our joint company. Fresenius Medical Care has access to more than 329,000 patients in its global network of over 3,900 dialysis clinics.

Contact Us
  • Flughofstrasse 61
  • 8152 Glattbrugg
  • Switzerland
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