Description
Guten Tag Ich hoffe es geht Ihnen gut?GernemöchteichSiehiermitübereineneue Position informieren:
Quality Manager
COMPANY: (Biopharma)
REGION: Zentralschweiz
DAUER: asap - 01.02.2017
RATE: all in CHF /h, bitte angeben
Bitte finden Sie die komplette Stellenbeschreibung unten in English.
QA Specialist: (Division: Quality Development) Direct Reports None Major Interfaces All departments of the company.
Aim of the Position:
* Ensuring that products, systems and facilities are in state of sustainable compliance with the requirements of cGMP and regulatory authorities.
* Responsible for all quality matters related to the activities performed in the production and during process development.
* Assure efficient and effective quality assurance activities at required cGMP level.
* Assure that the products are manufactured according to cGMP requirements.
* Together with the team, support operations and / or development with cGMP guidance on all strategic decisions. Essential duties Operational
* Ensuring compliance of products, processes, systems and equipment with global and local guidelines and procedures as well as with legal or regulatory requirements.
* Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality related documents.
* Review and approve Raw Materials.
* Perform batch record review and batch disposition.
* Review, assess and approve local Change Controls. * Review and assess global Change Controls.
* Review and approve event and deviation reports. Assess event and deviation reports for any need of escalation to the Manager Quality Development.
* Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation.
* Ensure appropriate coverage of CAPAs by effectiveness checks, follow up their execution and evaluate the results.
* Support Manager Quality Development in evaluation of PTCs and ADRs. Review release package (including samples).
* Review and approve certifications for Health Authorities.
* Support in compilation of the PQRs. cGMP compliance
* Manage and further develop the quality system.
* Increase cGMP understanding within Crucell including training.
* Support inspection team during preparation, execution and follow up of inspections and audits. Competencies Operational
* Review and approval of changes.
* Review and approval of CAPAs.
* Review and approval of investigation, events and deviations reports.
* Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality documents.
* Review an release of raw materials specification documentation.
* Review and approval of raw materials.
* Review of MBRs, Batch Production Records, including all supporting documentation (for example, test results)
* Compilation of batch dossier for batch release
* Perform QA release of batches and intermediates.
* Set batch status in LIMS and SAP excluding QP release.
* Take over equivalent competencies for other products if delegation approved by the qualified person.
* Requesting for blocking of equipment, processes and products.
* Definition of quality related corrective and preventive actions. Responsibilities As described before. Performance Measurement Fulfillment of duties and tasks as described before and as to be defined in the yearly performance talks.
Requirements General:
* Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements.
* University degree in natural sciences, medicine or pharmacy or professional scientific, medicinal or pharmaceutical training and several years working experience under cGMP.
Quality:
* Know how of quality assurance principles (cGMP).
* Know how of biological manufacturing processes.
* Profound know how of Quality Assurance.
* Inspection experience.
* Know how of risk management.
Management Skills:
* Analytical thinking and problem-solving ability.
* Communication ability and Good negotiation skills.
* Time and self-management
* Multilingual - at least German and English, written and spoken
Sollten Sie Interesse haben, würde ich mich freuen von ihnen zu hören.
Somit können wir dieses und eventuell andere Projekte besprechen.
Bitte sehen Sie weitere Positionen für die genannte Firma:
- GMP USP/DSP Team Leader
- GMP Qualification / Validation (Equipment,CSV)
- GMP Qualification / Validation (Equipment,Process) Auch für diese Stellen kann ich Ihnen gerne die Stellenbeschreibung zukommen lassen.
Ich freue mich von Ihnen zu hören.
Beste Grüsse
S. Keel