quality assurance associate iii in Solothurn

posted
contact
Nicolae-Ionut Baias, Basel Professionals Health Care & Life Sciences
job type
contract
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job details

posted
location
solothurn
sector
life sciences
job type
contract
reference number
17882
contact
nicolae-ionut baias, basel professionals health care & life sciences
phone
058 201 55 50

job description

For our client, an international company in Solothurn we are looking for Quality Assurance Associate III

 

  • Start date: ASAP
  • End: 31.01.2023
  • Extension: possible
  • Workplace: Solothurn
  • Workload: 100%
 

The QA 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, 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.

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.

Tasks and responsibilities:
  1. Review of the Protocols related to Cleaning in Service of the manufacturing equipment until completion of the Cleaning validation
  2. Support deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
  3. Support cross functional groups on root cause analysis and corrective and preventive actions, strategy definition and processes improvement
  4. Provide quality oversight of change control process to support manufacturing process successful life cycle management
  5. Develop and maintain the KPIs of the Solothurn QA ops department, in collaboration with Manufacturing and Operational excellence department
  6. Revise and approve Standard Operating Procedures, work Instructions and documentation as needed.

 

Must have:

  • Bachelor or equivalent in Life Science or Technical discipline
  • Prior experience in GMP manufacturing site activity is mandatory.(Prior experience in automated environment is an asset.)
  • Should have proficiencies with the Quality systems and GMP knowledge .
  • 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.
  • Experience in the qualification of facilities, utilities , equipment and processes