Analytical Compliance Record Specialist
Analytical Compliance Record Specialist- Laboratory Technician / Organic Chemistry / Analytical Chemistry / Pharmaceutical / Biotech /GMP / CAPA / Deviations / Quality Control / Change Control English
Background:
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops creative technical solutions to bridge early- stage, late-stage and commercial product needs. The mandate of the group is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD and MS&T across our manufacturing network. This position on offer is located in Analytical Development Synthetic Molecules withinPharma Technical Development.
Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of our work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.
The Perfect Candidate:
The ideal candidate holds a Master's degree (or higher) in Organic Chemistry, Analytical Chemistry, or Pharmacy, possesses at least 3 years of professional experience in Quality Control, and has excellent GMP knowledge.
Tasks & Responsibilities:
• Work in a modern quality control organization in compliance with cGMP regulations.
• Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
• Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
• Facilitation and Documentation of Root Cause Analyses
• Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
• Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
• Critical evaluation of own work results
• Key role in ensuring an appropriate GMP standard in the department
• Scientific and regulatory documentation of the work done
Must Haves:
• Advanced Degree: A university degree (Bachelor's, Master's, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology)
• Alternative Qualification: Candidates with a Laboratory Technician background will be considered if they possess over 10 years of high-level GMP experience
• Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
• Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
• QMS Software: Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise)
• Core Competencies: Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs
• Business fluency is mandatory (written and spoken) for documentation and stakeholder management
• Proficiency in German is considered a strong asset and highly beneficial for internal communication
Nice to Haves:
• Roche Experience
• Prior experience as a Deviation/CAPA Owner or previous experience in a Quality Assurance (QA) role
Reference Nr.: 924935
Rolle: Analytical Compliance Record Specialist
Industrie: Pharma
Location: Basel
Pensum: 100%
Start: Asap ()
Duration: 12+ months
Deadline:
If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. jid0270d72ja jit0519ja jiy26ja