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Clinical Compliance Specialist
| Category | QA, QC & Validation |
|---|---|
| Job Ref | DJ/HQ00007817 |
| Job Type | Permanent |
| Salary | CHF 100000.00 - CHF 110000.00 per annum |
| Location | Switzerland - Basel |
09 Mar 2010
The Clinical Quality Assurance, Country Managers are compliance specialists within the Global Clinical Quality Assurance team.
RESPONSABILITIES
Proactively address quality related issues and stimulate the quality mindset of all parties accountable for local clinical quality assurance in the Country Pharma Organization (CPO), region EU.
Provide quality regulatory advice, support and guidance to the CPOs to ensure compliance in GCP, PharmacoVigilance, e-compliance and clinical trials
Support the countries in achieving their quality objectives and to ensure compliance with global and local GCP, PV, e-compliance and regulatory requirements
Upon completion of an audit, in cooperation with the auditor, the Country Manager provides assistance to the auditor in the country upon request for Corrective and Preventive Action planning and resolution.
Provide assistance to the CPO in all matters of preparation, conduct and follow up in Health Authority inspections, including Corrective and Preventive Action planning and resolution.
REQUIREMENTS
Minimum: Life science degree or equivalent; Broad knowledge of the pharmaceutical industry, practical workplace experience, preferably in Clinical Development and Pharmacovigilance and Validation;
Expertise in the application of clinical development, GxP and pharmacovigilance requirements and processes; Understanding of clinical trial methodology and medical terminology;
Knowledgeable and application of computer system validation and 21 CRF part 11 requirements; Effective communication, negotiation and leadership skills; Ability to work effectively in a team environment, in multiple roles; Effective training and facilitation skills;
Prior experience managing Health Authority inspections (FDA, EMEA, etc.). Preferred: Quality Audit Certification (ASQ, BARQA, ISO or equivalent); Multi-lingual; Ability to work independently; Technical and practical expertise in management for quality, and regulatory requirements; Strong problem solving and decision making skills with the ability to identify key risk areas and establish appropriate follow up; Ability to multitask and prioritize appropriately and to maintain focus while managing multiple projects; Ability to build trust and integrity;
Organizational skills; Ability and flexibility to respond to and facilitate constant changes as a means of continuous improvement; Thorough understanding of Client Standard Operating Procedures / Client Internal Procedures; Understanding of cultural differences and diversity; Strong computer skills.
For further information please contact
Daniel Jones
Email: daniel.jones@hayspharma.com
Services advertised by Hays Pharma are those of an Agency and/or an Employment Business
