sr. specialist qa disposition in Basel

posted
contact
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
job type
contract
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job details

posted
location
basel, basel-stadt
sector
life sciences
job type
contract
reference number
15170
contact
lucie nasshan, basel professionals health care & life sciences
phone
058 201 55 50

job description

To work for our client, a pioneering biotechnology company, we are looking for a: 

Sr. Specialist QA Disposition

Location:Basel

Contract: to start asap for one year.

This role requires fluency in German. 

We are looking for a Sr. Specialist QA Disposition to provide QA oversight and support of international organization’s product disposition of clinical and commercial products manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). 

The Sr. Specialist QA Disposition will ensure clinical and commercial drug substance and drug product as well as labeled and packaged product complies with cGMP, international regulatory requirements, and internal policies, procedures and specifications. 

The incumbent will collaborate with Manufacturing, QC, QA Operations, QA Systems and Compliance, Regulatory Affairs and Supply Chain to ensure products are dispositioned on time to meet defined turnaround times to meet supply and customer requirements and work with Qualified Person (QP) to support release to EU countries.  

The incumbent will be an integral partner to the innovative technology platform as we continue to integrate automation and digital technology into everything we do. 

 

Your Responsibilities: 

  • Review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications. 

  • Approve certificates of analysis and certificates of compliance in support of product disposition. 

  • Support overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines. 

  • Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls). 

  • Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures. 

  • Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria. 

  • Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues in support of product disposition activities. 

  • Facilitate and coordinate disposition of product for applicable regions and markets with Regulatory Affairs (RA), Qualified Person (QP) and Supply Chain (SC).  

  • Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.

Your profile:

  • Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years.

  • Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections.

  • Experience in product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry.

  • A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.

  • Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way. 

  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.

  • Experience working with CMOs, CLOs, vendors, and relationship management preferred

  • Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment. 

  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

  • Ability to navigate through ambiguity and rapid growth and adapt to change. 

  • A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

 

Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position