Beschreibung
Randstad Professionals Zurich is actively looking for a Senior Quality Technical Manager to join our client in Basel, Switzerland.
The purpose of this position is to provide quality oversight and expertise for the selection, implementation and management of Contract Manufacturing Organizations used for the manufacture of clinical small molecule GMP intermediates, APIs and drug products. This position leads quality system development and implementation as well as business process improvements. The incumbent serves as a subject matter expert for the development and implementation of quality systems as they apply to Small Molecule development and production. The position will also provide QA Validation support for Small Molecule programs and may be part of Technical Development (TDT) teams.
Reponsibilities
- Represent the External Quality Small Molecules on TDT teams as needed, to include CMO Quality Systems assessments, assuring CMO cGMP compliance, managing quality risks, and tracking appropriate metrics. The contractor will also be responsible for reviewing Master Batch Records (MBRs), executed batch records and any associated deviations and investigations.
- Prepare Quality Agreements and corresponding Product Specific Requirements (PSRs).
- Negotiate and maintain Quality Agreements with selected CMOs and ensure the requirements of the Quality Agreement are fulfilled (in collaboration with other quality functions).
- Provide technical expertise and guidance to the External Quality Small Molecules organization by supporting or managing deviations and investigations, changes, specifications and regulatory submissions.
- Participate in due diligence visits to assess CMO Quality Systems for development and processing of investigational medicinal products.
- Build strong relationships with both internal operations units and external CMOs. Collaborate with internal departments to achieve goals through aligned processes.
- Participate in the design, implementation and maintenance of quality systems for Small Molecules for execution of the above function.
- Provide equipment/facility qualification and process validation support to Small Molecule programs. Implement appropriate systems as necessary. Review and approve validation protocols per the Quality Agreement.
- Perform quality risk assessments, develop mitigation plan and follow-up on implementation.
- Provide input in the design of sampling plans and product specifications for API and drug product.
- Coordinate the QC requirements between the CMO, internal and or other contract testing laboratories.
- Review master batch records for compliance to clinical trial protocols, regulatory filings, product requirements and cGMP compliance.
- Review CMO analytical method transfers and method qualifications protocols/reports with QC.
- Ensure that manufacture and release of clinical supplies of our client's Small Molecule GMP intermediates, API and Drug Product at CMOs is conducted in accordance with cGMP.
- Participate as a person in the plant and provide oversight of the CMO quality unit in order to facilitate timely initiation, assessment, review, and closure of discrepancies and investigations.
- Escalate gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure and HSE issues with regard to quality and time.
- Perform Pre-approval inspection checklists at CMOs that will be manufacturing Commercial materials for our client.
Qualifications
- At least 10 years of experience in pharmaceutical in manufacturing, quality assurance or quality control
- At least 5 years of project experience in a quality role
- At least 3 years of experience in operating quality systems in pharmaceutical operations
- Demonstrated proficiency in interpretations of cGMP regulations, both US and international
- Ability to travel between 15%-25%
- Proficiency in BOTH German and English
Duration: 1 year
Starting date: ASAP
Service level: 100%
If you're looking for a new opportunity and you fulfil all of the qualifications, please don't hesitate to contact me! Good to know you.