Halden Pharma is looking for a new engineer for QC Validation

Purpose/Summary of Position:

• Analytical method validation, verification, co-validation, method transfer.
• Qualification and implementation of analytical instrument into QC laboratory

Responsibilities / Duties:

• Validation, verification, co-validation, method transfer and implementation of analytical methods for new and existing finish products / raw materials
• Review and approval specifications for analytical chemistry methods (11 spec), raw materials (02 specs), and components (04 specs). Ensure that all established specifications are in compliance with current pharmacopeias and GMP regulation.
• Training of laboratory personnel in new analysis methods or instruments.
• Qualification and implementation of the new analytical instruments.
• Creation and approval of all relevant quality documents: SOPs, protocols, reports, specifications and method of analyses.
• 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

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

What we offer:

• A healthy balance between work and leisure with flexible working conditions
• Excellent pension and health insurance schemes
• Opportunities to participate in activities organized by the company's sports club
• Great company cabins at Tanumstrand

If you want more information about the position, please contact the department manager.