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GMP Quality Control Deputy Manager
Description de la fonction
GMP Quality Control Deputy Manager
Do you have experience in quality control? Do you have a scientific background? Do you speak English fluently?
So, you are the next GMP QC Deputy Manager of our client!
Our client is a global provider of innovative products and services for the life science industry.
As support to the QC Manager, the Scientific and Regulatory Deputy Manager will ensure Quality, Regulatory and Scientific compliance with the QC GMP. The deputy Manager will lead regulatory, delivery, cost and quality strategy. He will ensure that improvement plans and CAPA plans are performed and implemented. He will lead the QC advisor group in order to set up a support group within the QC GMP.
Your main responsibilities are:
- Regulatory, Scientific and Quality mission:
- Ensure that GMP practices are aligned with the current guidance's and scientific knowledge
- Lead a team of QC advisors
- Lead investigations and corrective and preventive action plans pertaining to non-compliance issues
- Provide scientific and regulatory support to laboratory technicians, project leaders, management
- Back up of the manager during audits, inspections, prospections and follow ups
- Interact with the QA team in order to develop an effective QMS for the QC
- Review SOPs, protocols and final reports to assure compliance with regulation, and company SOPs
- Attend conferences as well as continuing-education and development activities to be up to date.
- Projects Follow up/Continuous improvement:
- Supervise LIMS implementation and follow up (milestones, timelines, people training, troubleshooting, ...)
- Supervise continuous improvement projects
- Develop relevant KPI's in order quality, cost, delivery indicators
- Analyse the main problems, find the rootcause, propose action plans and priorities
- Actively contribute to the qualification and validation process and method transfer
- Accountable for the qualification of lab equipment (URS, protocols, validation plan, reports)
- With his team, he is the referent key user for the software used in the lab
Keywords: #GMP #QC #QualityControl #ContrôleQualité #Management #Manager #Qualification #Validation #GMPpractices #LIMS #Audits
- You have a Master degree in Science
- You have experienced in pharma industry in quality and compliance environment. Preferred GxP auditing skill
- You have an excellent attention to detail, organizational skill, and previous experience with data review.
- You are rigorous and reliable.
- You are proactive, autonomous and knowledgeable of Methods (Lean, problem solving, …)
- You are stress resistant, a problem solver and you have an out of the box mindset.
- You have coaching and mentoring, Team player, Management skills
- You have good oral and written communication skills and effective interpersonal skills
- You are fluent in English
- Knowledgeable of USP, Eu. PH., FDA and EMA guidances, ICH, 21 CFR part 1
We offer you a permanent contract in a dynamic company.
Interested ? Contact
32 2 289 66 80
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- Type de fonction : Qualité
- Secteur : Chimie
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