Zurück zur Suche.SEC Recruitment Ltd - Quality Manager Compliance GMP
| Beschäftigungstyp: | Permanent |
| Standort: | Switzerland |
| Gehalt: | €80000 - €150000 per annum + Standard benefits package |
| Sprachen: | Englisch, Deutsch |
Details für die Anzeigenschaltung
- Name:SEC Recruitment Ltd
- Veröffentlichung:21-09-2010
- Code:746001sba
Responsibilities:
• Handles in cooperation with Corporate Quality & Compliance, CQM, the approval and qualification of suppliers of API, bulk drug products, quality control laboratories, packaging services and packaging materials including auditing and establishing Technical/Quality Agreements
• Handles in collaboration with Corporate Quality & Compliance, CQM, the approval of GMP Material suppliers for the Company’s International production site
• Is responsible for the compilation of the Annual Quality Review Report and the Product Quality Review according the Swiss-, EMEA- and FDA-requirements
• Is responsible for the internal GMP-audits process including the yearly internal audit plans necessary, the writing of audit reports (paper or electronically) and is responsible for the follow up and the implementation of the internal audit CAPAs
• Has the overall ownership of the deviation handling, the investigation and the CAPA system including the electronic systems in place
• Is responsible for the successful preparation of site authorities inspections in collaboration with the QA compliance specialists
• Acts as QA representative during authorities inspections as Subject Matter Expert
• Assist in the improvement of existing processes and the development of new processes or sub-processes related to the QMS
• Prepares a monthly trending of Deviations, CAPAs, internal audits and external audits, either as part of shared KPIs or separately, for the Head of International Quality Operations
• Assigns tasks to direct reports in accordance with their responsibilities and capabilities
•
Requirements:
• At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry
• MSc or equivalent in Science, or related field
• Thorough understanding of GMPs and Swiss, EU, and FDA regulatory requirements
• Solid understanding of solid oral dosage form manufacturing processes and QC testing methods
• Proven experience in people management and excellent interpersonal, collaborative and organizational skills
• Works independently, yet effectively in a team environment
• Ability to focus attention to details
• Excellent written & oral communication skills
• Excellent investigational and QA problem solving skills
This company offers great carrier progression and benefits such as: relocation package, excellent salary, pension scheme and private health care.
If you think you are the right person for this job, please send your CV to Stephanie.Broize-Arrieu@secpharma.com or call Stephanie on 0207 255 664 for more details.
• Handles in cooperation with Corporate Quality & Compliance, CQM, the approval and qualification of suppliers of API, bulk drug products, quality control laboratories, packaging services and packaging materials including auditing and establishing Technical/Quality Agreements
• Handles in collaboration with Corporate Quality & Compliance, CQM, the approval of GMP Material suppliers for the Company’s International production site
• Is responsible for the compilation of the Annual Quality Review Report and the Product Quality Review according the Swiss-, EMEA- and FDA-requirements
• Is responsible for the internal GMP-audits process including the yearly internal audit plans necessary, the writing of audit reports (paper or electronically) and is responsible for the follow up and the implementation of the internal audit CAPAs
• Has the overall ownership of the deviation handling, the investigation and the CAPA system including the electronic systems in place
• Is responsible for the successful preparation of site authorities inspections in collaboration with the QA compliance specialists
• Acts as QA representative during authorities inspections as Subject Matter Expert
• Assist in the improvement of existing processes and the development of new processes or sub-processes related to the QMS
• Prepares a monthly trending of Deviations, CAPAs, internal audits and external audits, either as part of shared KPIs or separately, for the Head of International Quality Operations
• Assigns tasks to direct reports in accordance with their responsibilities and capabilities
•
Requirements:
• At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry
• MSc or equivalent in Science, or related field
• Thorough understanding of GMPs and Swiss, EU, and FDA regulatory requirements
• Solid understanding of solid oral dosage form manufacturing processes and QC testing methods
• Proven experience in people management and excellent interpersonal, collaborative and organizational skills
• Works independently, yet effectively in a team environment
• Ability to focus attention to details
• Excellent written & oral communication skills
• Excellent investigational and QA problem solving skills
This company offers great carrier progression and benefits such as: relocation package, excellent salary, pension scheme and private health care.
If you think you are the right person for this job, please send your CV to Stephanie.Broize-Arrieu@secpharma.com or call Stephanie on 0207 255 664 for more details.
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