The QA Operations Associate III assures that all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformance. Collaboration with product Quality Management and collaboration and oversight of Manufacturing Operations and review/audit of data and reports as specified by SOP. This position will support quality key metrics and analysis. In addition, this role is expected to be cross-functional between the Quality team and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.

Company profile

Within the Pharmaceutical Industry globally & successfully operating company.

Place of work

Solothurn

Start of work

01.12.2020

Motivation

A dynamic working environment focusing on career opportunities where multi-cultural teams from all over the world strive the best results.

Education

Bachelor in Science/Engineering in Life Science or Technical discipline

Experiences

The suitable candidate has several years of Quality Assurance experience and shows expert level knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Prior experience with fully electronic operations and management is preferred. Experience in manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. In addition, any experience with LEAN, Six Sigma and continuous improvements, as well as drug substances (or API) and drug product are beneficial too. The candidate is able to work in shift model including during weekends. Moreover, he or she is a great communicator. Please apply directly to Nadin Schwarzenbach n.schwarzenbach@universal-job.ch

Languages

German: Good
English: Very good
additional languages beneficial 

Specials

This is a temporary position is by now offered until 31.03.2020 with the option to get extended. Client reference number BIOBJP00002485 (please integrate into your application).

Job number

P-6-10176

Senior Quality Assurance Associate

The QA Operations Associate III assures that all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformance. Collaboration with product Quality Management and collaboration and oversight of Manufacturing Operations and review/audit of data and reports as specified by SOP. This position will support quality key metrics and analysis. In addition, this role is expected to be cross-functional between the Quality team and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.

Company profile

Within the Pharmaceutical Industry globally & successfully operating company.

Place of work

Solothurn

Start of work

01.12.2020

Motivation

A dynamic working environment focusing on career opportunities where multi-cultural teams from all over the world strive the best results.

Education

Bachelor in Science/Engineering in Life Science or Technical discipline

Experiences

The suitable candidate has several years of Quality Assurance experience and shows expert level knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Prior experience with fully electronic operations and management is preferred. Experience in manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. In addition, any experience with LEAN, Six Sigma and continuous improvements, as well as drug substances (or API) and drug product are beneficial too. The candidate is able to work in shift model including during weekends. Moreover, he or she is a great communicator. Please apply directly to Nadin Schwarzenbach n.schwarzenbach@universal-job.ch

Languages

German: Good
English: Very good
additional languages beneficial 

Specials

This is a temporary position is by now offered until 31.03.2020 with the option to get extended. Client reference number BIOBJP00002485 (please integrate into your application).

Job number

P-6-10176

Universal-Job AG, Zug
Frau Nadin Schwarzenbach
Recruiterin
Baarerstrasse 43
6300 Zug
041 725 23 10

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