Analytical Development and Quality Assurance Specialist
Vor 4 Tagen
Job Title: Analytical Development and Quality Assurance Specialist
About the Role:We are seeking a highly skilled and experienced Analytical Development and Quality Assurance Specialist to join our team at TN Switzerland. As a key member of our analytical department, you will be responsible for managing a team of up to 3 direct reports and overseeing a project portfolio of up to 4 small projects or 1-2 highly complex projects.
Main Responsibilities:
- Manage laboratory activities, ensuring compliance with Good Documentation Practices and GMP regulations.
- Develop, optimize, and implement analytical methods for purity, stability, cleaning verification/validation, excipients, content, and genotoxic impurity determinations.
- Represent AD/QC in technical project teams and CMC meetings.
- Conduct release, retest, stability studies, transfer, and validation analyses.
- Ensure proper documentation of all analytical activities, including raw data and test results.
- Review and interpret analytical data, including method development, release, retest, validation, stability, and transfer results.
- Write and review analytical protocols and reports, establish specifications, and ensure maintenance and operation of analytical equipment according to GMP.
- Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.
- Organize GMP qualification and validation of analytical equipment with external companies.
- Elaborate qualification plans and review qualification documents.
- Ensure initial and continuing training of personnel and adapt to business needs.
- Maintain cleanliness of laboratories and workspaces.
- Independently design and execute projects or experiments with hands-on involvement.
- Review scientific work in project-related activities.
- Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.
- Contact third parties for defined analytical tasks.
- Evaluate and develop novel analytical techniques and instrumentation.
- Leverage workload of respective project members to meet timelines and budgets.
- Establish source documents for IND, IMPD, and NDA/MA submissions and respond to agency questions.
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks.
- Set and accomplish product development timelines working closely with formulation scientists.
- Responsible for management of GMP laboratories and employees.
- Responsible for analytical expertise for defined drug substances and/or drug products.
- Summarize, defend, and communicate results and product quality issues to management.
-
Quality Assurance Specialist
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitCTC Resourcing Solutions is a specialist industry expert in talent sourcing, HR, and consulting services. We are working with a leading CDMO company located in the Basel area to find a Quality Assurance Specialist for a 12 months contract initially.About the Role:The Quality Assurance Specialist will play a crucial role in supporting the setup,...
-
Senior Quality Assurance Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz gloor & lang Pharma and Biotech Recruiting VollzeitJob Description:The role of Senior Quality Assurance Specialist is crucial in ensuring the highest standards of quality are maintained throughout the product lifecycle. As a key member of the global quality team, you will be responsible for leading quality improvement initiatives and providing regulatory oversight on all product quality aspects.Your...
-
Quality Assurance Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Talentify VollzeitTalentify is a leading provider of digital transformation services, and we are seeking an experienced IT professional to join our team as a Quality Assurance Specialist.As a Quality Assurance Specialist, you will be responsible for overseeing the migration and rollout of Windows clients and servers in laboratory and manufacturing environments. This role...
-
Pharmaceutical Quality Assurance Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Elvium VollzeitAbout the RoleWe are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team at Elvium. As a key member of our quality assurance department, you will be responsible for ensuring that all aspects of our pharmaceutical operations meet the highest standards of quality and regulatory compliance.The ideal candidate will have a deep...
-
Quality Assurance Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz gloor&lang AG VollzeitAs a Quality Assurance Specialist in our organization, you will play a key role in ensuring the highest standards of quality in the pharmaceutical sector. Your primary responsibility will be to support the strategic development of an effective global risk-based audit strategy. This involves planning, leading, conducting, documenting, and following up on...
-
Quality Assurance Specialist
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Avance Consulting VollzeitEmpowering Talent in the UK and EU, Avance Consulting is a leading provider of IT and Engineering services.Job Title: Inspector Quality AssuranceJob Type: PermanentJob DescriptionPosition and Responsibilities:Ensure adherence to applicable procedures as per DOE, POE, MOE, CAME, and other Specifications.Maintain effective communication and liaison within the...
-
Director of Analytical Quality
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitDepartment OverviewThe 'Analytical Development and Quality Control' department plays a critical role in ensuring the quality and safety of TN Switzerland's biopharmaceutical products.We are seeking an experienced leader to join our team as Director of Analytical Quality.Key responsibilities include:Developing and implementing departmental strategies and...
-
Quality Assurance Manager
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitCompany OverviewCTC Resourcing Solutions is a specialist recruitment agency providing reliable HR and consulting services to the pharmaceutical industry. Our team of experts helps companies source top talent and provides support for career development.We are currently working with an innovative mid-size pharmaceutical company with global headquarters in...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitFor our client's company in Basel, we are looking for aQuality Assurance Manager- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)- You maintain, record and process corrective and...
-
Quality Assurance Manager
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitFor our client's company in Basel, we are looking for aQuality Assurance Manager- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)- You maintain, record and process corrective and...
-
Clinical Quality Specialist
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitClinical Quality SpecialistWe are seeking a highly motivated and committed Clinical Quality Specialist to join our team at TN Switzerland for an 18-month assignment. As a Clinical Quality Specialist, you will be responsible for delivering Investigational Medicinal Products (IMPs) to patients in compliance with cGMP. You will work closely with packaging...
-
Analytical Development Manager
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitJob DescriptionWe are seeking a highly experienced and skilled leader to oversee the analytical development and quality control of biopharmaceuticals. As Analytical Development Manager, you will lead a team of experts in developing, validating, and executing analytical methods for biopharmaceuticals from pre-IND stage to BLA and launch.Key responsibilities...
-
Research and Development Expert
vor 18 Stunden
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche AG VollzeitKey ResponsibilitiesThe successful candidate will be responsible for developing and running high-resolution Mass Spectrometry (MS) methods for the analysis of synthetic oligonucleotides.Additionally, they will serve as the Analytical Molecular Characterization Leader, providing matrix leadership and scientific expertise to a diverse team of analytical...
-
Senior Quality Assurance Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitWe are currently looking for a Senior Quality Assurance Specialist to support our client in Basel area, Switzerland. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in GCP and PV regulations.Main Responsibilities:Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites...
-
Senior Quality Assurance Manager
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitWe are looking for a seasoned GCP Compliance Specialist to join our team. As a GCP Compliance Specialist, you will play a critical role in ensuring that all vendors comply with GCP regulations.You will lead on-site or remote audits, evaluating compliance with GCP regulations, internal quality standards, and relevant guidelines.Prepare comprehensive audit...
-
Quality Assurance Specialist for Biologics
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit12 month contract - CMO Management for BiologicsAs a Quality Assurance Specialist, you will play a key role in ensuring the quality and compliance of biologic products. This exciting opportunity is part of our client's 12-month contract to manage their CMO (Contract Manufacturing Organization) activities in Basel.The ideal candidate will have a strong...
-
Quality Assurance Expert
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Mundipharma International VollzeitMundipharma International is seeking a Quality Assurance Expert to join our team in Basel, Switzerland.About the Role:This is an exciting opportunity for a seasoned professional with expertise in quality management and regulatory compliance to lead our quality assurance function.Responsibilities:Develop and implement effective quality management systems that...
-
Supply Chain Quality Assurance Manager
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitAbout the OpportunityWe are looking for a talented Supply Chain Quality Assurance Manager to join our team at TN Switzerland. As a Supply Chain Quality Assurance Manager, you will be accountable for maintaining and continuously improving the compliance of the Global Clinical Supply Chain organization with Roche PQS, GxP and Health Authority requirements.You...
-
GCP Quality Assurance Professional Basel
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz TN Switzerland VollzeitAbout the RoleWe are seeking a seasoned Quality Assurance professional to join our team in Basel. As a Senior QA Specialist, you will be responsible for providing oversight and support for GCP/PV/GLP activities within our company and at vendor/investigator sites.The ideal candidate will have a minimum of 5 years' experience in the pharmaceutical industry and...
-
Analytical Chemistry Specialist
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitWe are looking for an experienced Analytical Chemistry Specialist to join our team of scientists working on health and nutrition projects. As a key member of our research group, you will be responsible for analyzing complex biological samples using advanced chromatographic techniques.About the Role:Analyze and interpret data from chromatographic experiments...
