To work for our client, a pioneering biotechnology company, we are looking for a:
Sr. Specialist, External Quality Control
Contract: to start asap for one year.
We are looking for a Sr. Specialist External QC based in Basel, Switzerland to assist in overseeing Quality Control (QC) testing including in-process, release, and stability in support of contract manufacturing and testing facilities and overall international operations for the clinical and commercial products.
This position reports to the AD/D External QC for the International Organization and will help develop and implement QC methods, systems, policies, procedures and controls as they relate to QC testing of raw materials, drug substances and drug products and manage method lifecycle projects, coordinating across teams to meet business objectives.
Support oversight of testing program requirements at contract manufacturing and contract laboratory organizations for raw materials, drug substance and drug products and assist in overseeing overall day to day testing operations.
Manage in-process, release and stability testing, data trending, analysis and reporting to support timely release of product and ensure compliance to approved specifications.
Review executed QC test records for product release, including the investigation and resolution of deviations, Out of Specifications (OOS) and Out of Trends (OOT) observations.
Support execution of method transfers and method validation projects with contract manufacturing and contract testing laboratory organizations.
Author method acquisition and validation protocols and reports and author QC CMC sections for regulatory filings.
Monitor and communicate method lifecycle (acquisition, validation, implementation) timelines using project management tools.
Oversee and provide technical assessments for QC investigations, change control, and CAPA and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
Responsible for creating/revising and review/approval of QC policies, procedures, protocols and reports.
Lead continuous improvements of systems (procedures and systems) to improve organization effectiveness and ensure compliance. Support preparation, management and response to compliance audits.
Assist in Quality Metric review processes, assess data for adverse trends, develop solutions and oversee implementation.
Participate in and partner with the Digital team to expand and optimize the use of the LIMS system.
This role requires approximately 25% international travel.
Bachelor degree in relevant scientific discipline with applied cGMP laboratory setting industry experience of 5-8 years.
Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
Knowledge with QC operations including bioassay, chemistry, and microbiology and HPLC Instrumentation/ Software experience
Proven skills in technical writing for method validation documentation, QC trending reports, technical assessments for investigations and change controls and CMC sections of regulatory filings.
Working knowledge of relevant EU and global regulations and ICH standards/guidelines and experience in participating in successful regulatory inspections.
Experience in general laboratory operations, method acquisition, method validation, computerized systems, and manufacturing and testing within biotechnology industry.
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.
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
Randstad (Schweiz) AG