Quality Assurance/Quality & Validation Manager
Pharmadule Morimatsu AB / Kemiingenjörsjobb / Nacka
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Stockholm eller i
hela Sverige Are you experienced in QA and looking for a great opportunity to take you further in your career? Pharmadule Morimatsu AB is now offering a job opening as Quality Assurance/Quality & Validation Manager!
About Pharmadule Morimatsu AB
Pharmadule is the founder of the modular facility concept for the pharmaceutical industry. Since 2011 Pharmadule is part of Morimatsu Industry Group, an international manufacturer of tanks, heat exchangers, process skids and modules and other industrial systems to a wide variety of industries. Today the group operates on a worldwide basis with offices in Stockholm (Head Office), New Jersey, Shanghai, Mumbai and Milano.
With a strong presence in Asia, with engineering and manufacturing facilities in Shanghai, we are a perfect partner when setting up production in new markets. At the same time we can deliver very cost competitive projects to established markets.
Leading pharmaceutical companies such as Eli Lilly, Merck, Baxter, Lonza, GlaxoSmithKline, Genentech, Pharmacia and AstraZeneca have all used the modular approach for their new manufacturing buildings worldwide.
For more information please visit our website:
www.pharmadule.com.Responsibilities
As the Quality Assurance/Quality & Validation Manager you will dealing with two roles: one is a general QA role working with the company QMS, and the other is a project specific QA role.
Your responsibilities as the QA manager in the company QMS will be:
• Manage the company's Quality Management System, QMS
• Document Control
• Change Control
• CAPA
• Approve Supplier Quality Request (SQR) and Quality agreements
• Participate in Quality Management Review meetings
• Manage audits
• Follow up of KPIs
And your responsibilities as the project specific QA manager will be:
• Issue Project Quality Plan
• Issue Risk Management Procedure
• Issue Audit Procedure
• Plan and manage audits (client and internal)
- Perform Vendor Evaluation & Audit
- GMP responsibility in the project
- Perform GAP Analyses
- Quality Assurance
- Review design documents from a GMP perspective
Requirements
The educational background for the role as Quality Assurance/Quality & Validation Manager is:
• B.Sc. or M.Sc. in pharmaceutical, or biotechnical sciences, or engineering, or other degrees that the employer could find as equivalent.
• Experience QA and QA management, preferably within the pharmaceutical or biotech industry.
• Knowledge of cGMP manufacturing of pharmaceuticals and industry regulatory standards.
• Verbal and written communication skills in English and ability to communicate in a business environment.
Preferred personal skills/traits for the role are:
• Detail oriented and high levels of accuracy
• Solution oriented with the ability of critical thinking
• Responsive and communicative
• Accustomed to working in document management systems
• Team player with social skills
About the team and the work environment
The work environment with dynamic workflows and international atmosphere will invite you to develop occupational experiences and greater knowledge acquisition. You will be collaborating with competent colleagues with long experience in the industry. The international work arena with different quality lead processes is a great opportunity for developing greater perspectives within the role of QA Management.
We offer wellness benefits, pension deposits, insurance and life insurance.
Application and other information
This is a full-time assignment, starting as soon as possible. You will be working at our Swedish head office in Danvikstull Nacka. The role includes travelling abroad.
Recruitment and selection is an ongoing process, the assignment may be filled before the last application day, so do not hesitate to send in your application.
Send our application to
career@pharmadule.com and attach a CV and a cover letter for a more detailed presentation of who you are. The last application date is 2021-10-31.
Publiceringsdatum2021-10-01Så ansöker duSista dag att ansöka är 2021-10-31
AdressPharmadule Morimatsu AB
Hästholmsvägen 28
13130 Nacka
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Pharmadule Morimatsu AB (org.nr 556846-4910)
Hästholmsvägen 28 (
visa karta)
131 30 NACKA
Ansökan E-post:
career@pharmadule.com Jobbnummer 6009042
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