The company
Our client is a game-changer with a unique goal which is contributing to better care, such as the development of innovative therapies. Our client focuses mainly on patients with conditions for which few or no treatment options don’t exist, through the development of high-quality medicines.

Role description
As a Senior GMP QA Officer you are going to be responsible to conduct quality assurance supervision for equipment, automation, and information systems validation, as well as for managing quality risks. Evaluate and authorize validation documentation for equipment ensuring alignment. Offer advice and instruct operational personnel on adhering to quality policies, standards, and protocols.

Responsibilities 
-Collaborates on strategy and offers guidance for design, characterization, and validation ensuring GMP quality and compliance.
-Reviews and approves validation documentation.
-Reviews and approves equipment changes
-Conducts the final review of technical change controls, verifying that assessments from different stakeholders are complete and that all tasks are accurately documented in the record.

Requirements
-Bachelor’s degree in Life Sciences or a related field in process technology, or an equivalent combination of education and experience.
-At least 3 years of relevant experience in the pharmaceutical or medical device industry with a focus on Equipment and Automation Validation.
-Possesses knowledge of GMP, equipment and automation/IS validation, and computer compliance (Annex 11, Part 11).
-Familiarity with manufacturing and 1uality analytical processes and operations.
-Fluent in the English language.

Other information
Our client is seeking a highly motivated talents for different positions, do you want to join them and be part of an exciting journey. If you are interested or know someone who is, contact me via the apply button. I would be happy to discuss this opportunity with you.