QC Validation Engineer
HP Halden Pharma AS
- Frist 8.4.2025
- Ansettelsesform Fast
Become Our Next QC Validation Engineer at Halden Pharma!
Are you passionate about ensuring high-quality validation processes in a dynamic and regulated environment?
Halden Pharma is seeking a dedicated and skilled Validation Engineer to join our QC Validation and Compliance Department. In this pivotal role, you will contribute to ensuring that our laboratory and quality control systems comply with stringent industry regulations and standards.
Purpose of the Position:
- Analytical chemistry method validation, verification, co-validation, and method transfer.
- Qualification and implementation of analytical instruments in the QC laboratory.
Key Responsibilities:
- Perform analytical method validation, verification, co-validation, method transfer, and implementation for new and existing finished products and raw materials.
- Create and review relevant quality documents in compliance with current pharmacopeias and GMP regulations (SOPs, protocols, reports, specifications, etc.).
- Qualify and implement new analytical instruments.
- Provide training and support to laboratory staff on validated methods and best practices.
- Execute change control, event handling, and CAPA/action management processes in compliance with global QM standards.
- Represent the department during external audits.
Qualifications:
- University degree in Chemistry, Biotechnology, Pharmacy, or related fields (Bachelor/Master) or equivalent experience.
- Knowledge and experience in Quality Control release testing, Analytical Method Validation, Good Manufacturing Practice (GMP), and relevant regulatory guidelines.
- Proficiency in techniques such as HPLC, GC, ICP, TOC, UV, IR is preferred.
- Fluency in English. Proficiency in Norwegian is an advantage.
Personal Characteristics:
- Organized and quality-oriented.
- Proactive and goal-oriented.
- Positive mindset with an inclusive attitude.
- Ability to work in a structured, systematic, and dynamic environment.
- Strong communication and cooperation skills.
- Ability to work independently.
What We Offer:
- Career Development: Opportunities for continuous professional growth and development in an international environment.
- Meaningful Work: A role that plays a crucial part in ensuring safe and effective pharmaceutical products for global markets.
- Inclusive Environment: A collaborative and supportive work culture with an international team.
- Employee Perks: Access to corporate cabins for leisure, as well as participation in a company sports team and wellness initiatives.
If you are ready to take your career to the next level and contribute to a company committed to quality and innovation, we would love to hear from you!
Apply today and join Halden Pharma in shaping the future of quality control.
Om arbeidsgiveren
HP Halden Pharma AS, strategisk plassert ved Norges største innfartsåre, er en av de største og mest avanserte sterile produksjonsfasiliteter i Nord Europa.
Dette «state-of-the-art» anlegget produserer IV poser og plastampuller ved hjelp av en «blow-fill-seal» teknologi og andre farmasøytiske doseringsformer.
Anlegget var ikke bare en hjørnesteinsbedrift for den tidligere eieren Fresenius Kabi i Norden, men henvender seg allerede til andre fremtredende farmasøytiske kunder som kontraktsprodusent.
I Norge, har vi nå et anlegg i Halden med rett over 650 medarbeidere.
For mer informasjon, vennligst se vår hjemmeside: halden-pharma.com
- Sektor: Privat
- Sted: Svinesundsveien 80, 1788 Halden, 1788 Halden
- Bransje: Farmasi og legemiddel, Forskning, utdanning og vitenskap, Industri og produksjon
- Stillingsfunksjon: Analyse, Ingeniør, Kvalitetssikring
- Arbeidsspråk: Norsk
Nøkkelord
Analytical, Chemistry, Validation, Engineer, Quality Control
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Annonseinformasjon
- FINN-kode 399673668
- Sist endret