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.