ORGANISATION
Our partner is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world. We are the global leading experts, trusted by both pharmaceutical and biotech companies and healthcare professionals, in providing access to medicines throughout the lifecycle of a medicine; clinical trials, unlicensed and commercial supply.
We are currently 1000+ people, headquartered in the UK, with global offices in the US, Asia Pacific, South Africa, and across Europe. Our mission is to deliver the right medicine to the right patient at the right time and to help achieve this, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.
ROLE
This position is responsible for enabling CCSM to achieve best-in-class quality by taking the lead in Incident/Investigation and CAPA preparation while meeting scheduled timelines. This position partners with all functional area leaders and is result-focused by improving our Investigation/CAPA process.
- Support both Operations and Quality by writing and ensuring effective implementation of CCSMs Incident Reports, Investigations, Corrective and Preventative Actions documents
- Interview Subject Matter Experts (SMEs) and involved employee(s) investigating reported problems and assess the quality impact
- Schedule investigational meeting(s) with the required team members(s)
- Use problem solving techniques to identify root cause analysis, and develop strategic solutions based on employee interviews of each incident
- Assist Operations in standard operating procedure development as needed
- Document review and report generation as required
- Document maintenance, storage and coordination, as requested
- Communicate operational concerns and opportunities for improvement to department leaders
- Discuss incidents in weekly Operations meetings
- Know, understand and comply with CCSM’s standard operating procedures and policies
- Lead by example in setting a positive, supportive and team driven culture in working with team members to effectively resolve issues in a timely manner
- Perform other related job duties or responsibilities as assigned
REQUIREMENTS
- 1-4 years of work experience in document preparation
- Bachelor's Degree with 1 year of work experience or equivalent experience in documentation preparation
- Working knowledge of GMPs, CFR and ICH guidelines preferred
- Excellent written communication skills and active listening ability
- Excellent time management skills for working within a fast paced, ever-changing environment
- Must be a self-motivated learner to critically evaluate situations, adapt quickly in making timely and independent decisions
- Excellent communication and leadership skills
- Strong analytical and problem-solving skills
- Ability to work with cross functional teams and build consensus
- Maintain a high regard for confidentiality while dealing with all clients, proprietary and pharmaceutical related information
- All Microsoft Office Products: Word, Excel, Outlook, PowerPoint
- Other company proprietary software
- Fluent in English and in French
If you are interested, you can send your cv : [email protected]
