vor 2 Tagen

QA consultant

Akka Life Sciences

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The AKKA Technologies Group is a leading international Engineering and Technologies services company scattered in more than 20 countries around the world (Europe, Asia, Africa, America and Middle East) with over 15,000 employees.


To support the development of our activities, we are now looking for a:



 

QA consultant

The AKKA Technologies Group is a leading international Engineering and Technologies services company scattered in more than 20 countries around the world (Europe, Asia, Africa, America and Middle East) with over 15,000 employees.

To support the development of our activities, we are now looking for a:

 

Location: Neuchatel area, Switzerland


Description of the project:

 

- Responsible for the Quality Assurance (QA)

- Support sterile product batch review and release activities for assigned products:

- Deviations/OOS and CAPAs related to events occurring at manufacturing/testing sites

            - Product Quality Complaints (PQC) regarding assigned products / vendors

            - Product investigations

            - Change Control events from or to the vendor

- Master Batch Records (MBR) and associated production documentation

- Annual Product Review (APR), Product Quality Review (PQR)

- Technical and Quality Agreements (TQA)

            - QA tasks triggered by regulatory submissions

            - QA tasks triggered by QC topics

- Audits and inspections

- Quality management

- Provides support concerning requests for investigation or information pertaining to assigned quality topics.

- Maintenance/update of relevant Quality Operations and Corporate metrics as per assigned tasks

 


Profile:

- Min 5 years of experience in Quality Control or Quality Assurance in the pharmaceutical industry

- BSc/BA (or equivalent) in Sciences or a related discipline.

- Good knowledge of cGMPs and Swiss, EU, and FDA regulatory requirements.

- Solid understanding of solid oral dosage form manufacturing/packaging processes and QC testing methods.

- Works independently, yet effectively in a team environment.

- Excellent written & oral communication skills in both French and English.

- Good interpersonal and training skills.

- Ability to focus attention to details.

- Knowledge of most common office software.

 

 

If this sound like your next challenge, please send me your updated CV to megan.holmstrom@akka.eu or call me on +41 78 929 78 14 and I will contact you shortly to discuss it further.

 

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