We are looking for a Validation Engineer at QC Department

Are you passionate about ensuring high-quality validation processes in a dynamic and regulated environment? Halden Pharma is seeking a Validation Engineer to join our QC Validation and Compliance Department. In this role, you will play a key part in ensuring that our laboratory and quality control systems comply with industry regulations and standards.

Purpose of Position:

Analytical method validation, verification, co-validation, method transfer.

Qualification and implementation of analytical instrument into QC laboratory.

Responsibilities:

• Validation, verification, co-validation, method transfer and implementation of analytical methods for new and existing finish products / raw materials.
• Creation and review of all relevant quality documents in compliance with current pharmacopeias and GMP regulation (SOPs, protocols, reports and specifications and etc.)
• Qualification and implementation of the new analytical instruments.
• Training of laboratory personnel in new analysis methods or instruments.
• Change control execution, event handling and CAPA/ action management processes in compliance with the global QM.
• Representation of department during external audits.

Qualifications:

• Education from university in Chemistry/ Biotech/ Pharmacy equivalent to Bachelor/Master or/and experience from equivalent position.
• Experience within chromatography systems and different analytical techniques is an advantage.
• Knowledge and experience in Quality Control, Validation, Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5 is an advantage.
• Fluency in English and Norwegian (optional)

Personal characteristics:

• Organized and quality oriented.
• Proactive and goal oriented.
• Positive mind-set and an including attitude.
• Ability to work in a structured, systematic and dynamic environment.
• Good communication- and cooperation skills.
• Ability to work independantly.

What We Offer:

• An opportunity to be part of an innovative and growing organization.
• A supportive and inclusive work environment.
• Professional development opportunities.