SENIOR QUALITY ASSURANCE SPECIALIST (FTC - 18 MONTHS) - GERMANY - START ASAP
My client is a growing, fast-paced, global Clinical Research Organization (CRO) that has worked with all 10 of the world's top 10 pharmaceutical companies is currently looking for a Senior Quality Assurance Specialist for their office in Germany.
As a Senior Quality Specialist, you will be responsible for providing support to Business Process & Training (BP & T) / Process Quality Management and other operational staff in the implementation of processes, controlled documents, tools and templates to enhance quality of deliverables. This is a global opportunity so you will be required to liaise with clients across Europe and Asia-Pacific.
Activities include but are not limited to:
*Identification of process gaps and/or improvement opportunities; process authoring and review; support for process re-engineering; developing related training materials and/or delivering training.
*Providing GxP and process expertise to designated operational group(s); support for identification, management and prevention of project quality issues; providing audit and inspection support and overseeing the collection and reporting of project quality metrics.
*Provide support to operational staff on the application of, and adherence to processes and day to day use of in-house processes and systems used to manage a project, proposal or contract.
*Use process mapping and analysis techniques to identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans.
*Represent BP & T for SBU and Corporate process improvement initiatives, as needed.
*Work closely with BP & T, other Quality groups and Operations staff to ensure continuous process improvement.
*General ad-hoc administrative duties.
Requirements
*Primary language is English, German is an additional bonus
*Be educated to a Degree level, ideally in Pharmacy, Engineering, Chemistry or any other life science related subject such as biotechnology.
*Have a minimum of 3 to 5 years' experience in Quality Assurance and Quality Control within the pharmaceutical industry.
*Relevant experience in the Clinical Research field (pharmaceutical industry or CRO) or other relevant experience.
*Have a fantastic experience of GxP/GcP/GmP and Regulatory Standards within Pharmaceuticals.
*Be able to demonstrate excellent communication skills and problem solving ability.
*Experience of working in a global and fast paced environment.
*Relevant experience in the use and/or support of technologies (e.g. Impact, electronic filing systems) preferred.
Additional information:
-Possibility of being home-based
Please ensure you have the right to live and work in the EU before applying for this position.
If this role is of interest please send your CV to loic.ruffe@secpharma.com or call +44 207 255 6665 for a confidential conversation. http://uk.linkedin.com/in/loicruffe
