For one of our clients located in Solothurn in Switzerland, we are currently looking for a "QA Operations Associate III".
Job Description
The QA Operations Associate III, assures that all operations meet or exceed cGMP regulations.
Responsibilities
- Ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing,
- Warehouse 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.
- 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.
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
Requirements
- As such, the position is expected to have expert level 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.
- Dual Language preferred with a preferences for German and English.
- Prior experience with facility construction and start-up is an asset.
- Should have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
- Demonstrated ability to work autonomously and lead project
- Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Demonstrated problem solving skills
- Must have strong 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.
- Ability to work in shift model including during the weekend
- Experience in participating in pharmaceutical technology transfer team
- Experience in the qualification of facilities, utilities , equipment and processes
Benefits
- It concerns a short term assignment of 4 months.
- A balanced salary package based on your capabilities and experience,
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16391
