QC Specialist II

Job Description Summary

Job Description Summary
This position ensures the functionality of laboratory equipment through its (re-) qualification. This includes change management, deviation handling, and the execution of compliance tasks.

This position is limited for 3 years.

 

Job Description

Major accountabilities:

• Deviation handling, definition of CAPAs and Action

• Change management handling

• cGxP compliant review and approval of (re-) qualification activities of analytical devices (e.g. HPLCs, pH-Meter, pipettes, water baths) and release of those devices

• Performance of qualification of analytical devices

• Execution of compliance tasks (e.g. annual user review, periodic validation review, alarm reports)

• SME in customer and health authority inspections, and DQC implementation (e.g. Empower, LabX)

Essential Requirements:

• 3-5years experience in Pharma/Manufacturing sector in analytical lab or university degree in biology, chemistry, pharmacy or any other related field

• Working experience in the field of GMP production/Quality Assurance or Quality Control

• Good knowledge of MS office applications and other standard IT applications and security

• Risk Management, managing resources

• Quality Control Sampling and Quality Control (QC) Testing

• Laboratory Excellence and Innovative & analytical technologies

• Knowledge of TQM and related industry GxP standards and processes

• Fluent English and German required

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 59.781,96/ year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:  https://talentnetwork.novartis.com/network

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge, Statistics