quality assurance operations associate in Luterbach

posted
contact
Audrey Bisch, Basel Professionals Health Care & Life Sciences
job type
contract
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job details

posted
location
luterbach, solothurn
sector
life sciences
job type
contract
reference number
16335
contact
audrey bisch, basel professionals health care & life sciences
phone
058 201 55 50

job description

Do you want to work in a biotech company? Do you have at least 4 years experience in QA? You should then read the following lines!

 

Our client, based in Solothurn, is looking for a Quality Assurance Operations Associate III for a 8 months contract.

 

The Quality Assurance Operations Associate assures that all operations meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing and facility operations. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances. The holder will collaborate with product Quality Management for change control. 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.

As such, the position is expected to have knowledge in cell culture, purifications process, operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.

You work on the field, having an oversight over the manufacturing operations from a quality point of view and the electronic batch record review (QRM). You will review and approve Standard Operating Procedures (SOP) and you will perform ad hoc sampling and testing.

 

You report to the Quality Assurance Operations Supervisor and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA). You work in a 5-shift model along side the manufacturing team, within this you will work with other Quality Assurance Operations Associate colleagues and your Supervisor.

 

QUALIFICATIONS:

  • Previous experience in quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.

  • Good experience of process design and improvement.

  • Strong working experience with GxP regulations

  • Electronic Batch Record and elogbook management will be an asset

 

KNOWLEDGE AND SKILLS:

  • Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively

  • Demonstrated ability to work autonomously and lead project

  • Candidates with experience in drug substance (or API) and drug product are preferred.

  • Demonstrated problem solving skills

  • Proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.

  • Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)

  • Ability to work in shift model (night as well) including during the weekend

 

Do not waste any minutes, apply now!  We are looking forward to receiving your application.