QC Business Process Specialist
Location: Waterford
Contract: 23-Month FTC
About the job
At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need.
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical center that underpin a strong commitment to health and wellbeing.
The role is to ensure compliance in the QC Chemistry department at Sanofi is effectively maintained and enhanced.
Main responsibilities
•Raising, management and on-time closure of all Quality System processes including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
•Driving of all Quality Metrics for the department.
•Forward review of Quality Metrics to ensure no over-dues.
•Procedure effectiveness and simplification, and active contribution to continuous improvement initiatives.
•Ensure effective co-ordination and support for external and internal audits for the department.
•Perform critical / constructive review of procedures and practices. Identify and lead projects to make step-change improvements to the department's Quality.
•Conduct duties in a safe manner and report all safety issues or concerns.
•Support leadership team in achieving goals / tasks.
•Actively contribute to continuous improvement initiatives utilizing lean methodologies where appropriate.
•Liaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit Ready.
•Ensure all required training is completed on time.
•Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).
•Complete all duties as per relevant SOPs and global procedures.
•Ensure compliance to cGMP at all times.
About you
•Bachelor's Degree in Science/Engineering or equivalent.
•Minimum of 2 years' experience in a similar or related role.
•Extensive knowledge of cGMP and GDP in a regulated environment.
•Working knowledge of quality systems in a regulated environment.
•Understand relevant quality/compliance regulations.
Skills and Competencies
•Excellent accuracy and attention to detail.
•Excellent interpersonal skills.
•Excellent Communication skills.
•Initiative – be able to work in a self-directed manner to see issues through to completion.
Compensation
The salary range for this position is €48,000.00 - €64,000. Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
