associate operational quality downstream in Luterbach

posted
contact
Filipa Lessa, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
luterbach, solothurn
sector
Life Sciences
job type
temporary
reference number
11001
contact
filipa lessa, basel professionals health care & life sciences
phone
058 201 55 50
apply now

job description

To join our multinational biotechnology client, we are currently actively looking for a

Associate Operational Quality Downstream

Location: Luterbach, Switzerland Contract: 1 year with possibility of extension

Start date: as soon as possible

 

Responsibilities:

The QA Operations Associate assures that all operations meet or exceed cGMP regulations ensuring the quality of Bulk Drug Substance and Warehouse supporting on shop floor the daily manufacturing and facility operations and specifically performing on the floor sampling and testing of in process controls . The position needs reactive support of discrepancy identification. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis.

This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments. 

As such, the position is expected to have expert level knowledge in operations and business processes within a GMP Biotech environment.  Previous experience within GxP manufacturing will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have minimal experience with LEAN, Six Sigma and continuous improvements.

Accountabilities:

  • Handling shopfloor oversight over the manufacturing operations
  • Assist/perform in offline process sampling /testing
  • eBR and elogbook review
  • Reporting line to the Head of Operational Quality Downstream

 

Requirements:

  • Bachelor in Art/CFC in Life Science or Technical discipline
  • Approximately 1 to 2 years of any experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
  • Dual Language preferred with a preference for German and English.
  • Ability to work autonomously and to lead project teams in a matrix organization.
  • Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Ability of problem solving
  • Must have technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
  • Candidates with experience in drug substance (or API) and drug product are preferred.
  • Availability to work in shift model including during the weekend is mandatory
  • Basic experience in the qualification of facilities, utilities , equipment and processes

 

We are looking forward to receiving within your application:

  • your CV in English
  • latest Work Certificates
  • your Motivation Letter  
  • the date of your availability

 

Apply now to be considered

 

For more information and your application, please contact:   

  Filipa Lessa Professionals Life Sciences Recruiter

Randstad (Suisse) SA T: +41 58 201 55 60

filipa.lessa@randstad.ch