QA Specialist

Are you a QA Specialist interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Job Responsibilities

• The QA Specialist 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.
• 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 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.

Skills and Requirements

• 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.
• Experience in the qualification of facilities, utilities , equipment and processes

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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