QA Validation Specialist

Our customer in Helsingborg is offering a contractor position for an internal project within the Quality Systems &
Compliance department.
Products manufactured in Helsingborg are mostly over-the-counter pharmaceuticals and are produced, tested and released
according to good manufacturing practices (GMP). The Quality department is responsible for the quality management system
that ensures that the requirements set by health authorities worldwide are followed to assure safe products.


Om tjänsten
The QA Validation Specialist role is part of the Quality System and Compliance team. In this role you will support validation
activities and support site projects.
The position requires knowledge of cGMP and associated industry and regulatory guidance document to reviews and
approve reports and other sources of information to ensure that validations and procedures are in compliance with current
industry, regulatory requirements, and current technology

Dina arbetsuppgifter i huvudsak
Requires knowledge in Computer Software Validation
Possess min 10 years of experience in validation within an API, pharmaceutical, or biotech industry.
Knowledge of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance,
CAPA and Risk management).


Vem är du?
Education Level: (Pharmacist, Engineer, Biologist, Chemist, etc.)
Advanced level in Excel (mandatory & non-negotiable)

Language requirement: Excellent in English and Swedish (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, self-motivated, energetic and self-disciplined person
Problem solver
Fast learner
Good communication skills
Attention to detail
Able to work in a high-paced environment

Core competencies required for this role:
Requires knowledge in Computer Software Validation and Process Validation

Om verksamheten
This is a consultant assignment at a Pharmaceutical Company in Southern Sweden. During the period of the assignment you will be employed by Poolia.

Poolia Life Science is an authorized consultant and recruitment company with more than 30 years‘ of experience in matching qualified competence with world leading companies. Our dedicated team consists of highly experienced researchers and managers within the Life Science field, specialized in understanding the needs and expectations of clients´ as well as the competences and skills of the candidates´.