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!

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 Manageris:

-        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 2021-09-30.


NEWS

Pharmadule Morimatsu has successfully handed over China's First Modular mRNA Coronavirus Vaccine Facility within 7.5 month

Pharmadule Morimatsu AB  |   DanvikCenter 28  |   SE - 131 30 Nacka  Sweden  |   Phone: +46 (0)8 587 42 000  |   Email: info@pharmadule.com