Senior Clinical Quality Assurance Auditor
Covance is a market leading Contract Research Organisation, supporting the world's Pharmaceutical and Biotechnology businesses in bringing new medicines and to market. We have more than 11,500 employees in over 65 countries and a turnover in excess of $2bn.
We are currently recruiting for a Senior Clinical Quality Assurance Auditor to join our Maidenhead Clinical Development team.
Key Job duties for this role are listed below:
• Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfil client and Covance requirements.
• Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
• Assist with the allocation of QA&C staff to complete the required audits.
• Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
• Provide local leadership and line management as required on an informal / mentoring basis.
Qualifications:
• University/college degree, BA/BSc (life science preferred) or equivalent experience
• Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent experience is preferred but not essential
Experience:
• Typically a minimum of 4 Years experience in Clinical Quality Assurance, preferably with GCP experience.
• Or experience in other relevant professional roles within pharmaceutical/CRO environment.
• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
• Financial understanding of global clinical development budgets
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!