Quality Manager
vor 1 Woche
Site Name:
Switzerland - Muenchenbuchsee Bern
Posted Date:
Feb 9 2023
Quality Manager:
The job exists within the commercial Rx/Vx Local Operating Company to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met.
The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance.
The job holder is expected to support implementation of GMP and GDP requirements and sustaining the QMS on behalf of GlaxoSmithKline AG (GSK) and ViiV Healthcare GmbH (ViiV) including encouraging the Commercial Rx/Vx business to own quality activities in their day to day work.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:- Provide support in implementation and maintenance of an effective Quality Management System (QMS) to ensure that local operations are in full compliance with GMP and GDP and local regulatory requirements in Switzerland. Ensures furthermore that the QMS is in compliance with GSK standards and policies.
- Coordination of Product Quality Reviews (Periodic Product Reviews = PPRs) from manufacturing sites and technical writing of local evaluation reports (LERs) for local quality processes.
- Provide support in writing and revision of QMS SOPs
- Conduct selfinspections and audits
- Provide support in following quality processes:
- Complaints handling
- Change control management
- Deviation handling
- Corrective and preventive action (CAPA) management
- Regulatory Inspections.
_ Why you?_:
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Pharmaceutical technical assistant or bachelor in natural
- Minimum of 2 years experience in GMP/GDP area
- Experience in pharmaceutical industry or in a regulated environment
- Good knowledge of quality management systems
Additional Qualifications:
If you have the following characteristics, it would be a plus:
- Analytical mind, very good comprehension, attention to detail and structured
- Well organized, with good management skills and ability to work under pressure
- Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
- Flexible thinking able to challenge and see views form different perspectives
- Good team player works well in crossfunctional teams
- Professional written and verbal communication skills
- Language skills: German and English: fluent, French: basic/intermediate knowledge
- Computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook
_ Why GSK?_:
- Our values and expectations are at the heart of everything we do and form an important part of our culture._
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and wellbeing.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and costconsciousness.
_This is a job description to aide in the job posting, but does not include all job evaluation details._
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people.While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an Equal Opportunity/Affirmative Action Employer.All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GS
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