Join Halden Pharma as a Quality Engineer - Ensure Excellence in Pharmaceutical Production
Halden Pharma
- Frist 6.10.2024
- Ansettelsesform Engasjement
Quality Engineer
Summary of position:
Execution and implementation of new instruments and systems at the quality control laboratory in HP Halden Pharma according to regulatory and corporate requirements for qualification and validation and good data management. The position is temporary for one year after the start date.
Responsibilities:
- Write qualification validation documents and protocols (e.g., URS, DQ, FRS and IQ/OQ/PQ) for laboratory equipment and systems.
- Perform qualification and validation of analytical activities for instruments and computer systems to ensure compliance and functionality.
- Conduct periodic review of software systems and critical Laboratory instruments.
- Support calibration and maintenance of analytical instruments.
- Support and responsible for investigation of QC deviations related to computerized systems and equipment's according to applicable procedures and timelines.
- Execute change control, event handling and CAPA/ action management processes in compliance with the global QM
- Implement and adhere to all relevant QM documents for qualification, validation and data management.
Qualifications:
- Education from university in Chemistry/ Biotech/ Pharmacy/ Microbiology equivalent to Bachelor or experience from equivalent position
- Knowledge and experience in Quality Control, Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5
- Experience in computer system validation, GAMP5, Data Management and Data Integrity is an advance
- Collaboration and capacity to work cross functional/ sites/ cultures
- Drive change, transparent and communicate clearly
- Fluency in English, both written and orally
Personal characteristics:
- Positive mind-set and an including attitude
- Ability to build good relationships
- Ability to work in a structured, systematic, and dynamic environment.
- Good communication- and cooperation skills
- Proactive and goal oriented
- Organized and quality oriented
- Ability to make decisions
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
- Access to our corporate cabins at Tanumstrand
Quality Engineer or SME position will be assigned depending on the relevant education and/or experience for the position.
Please contact Laima Kasiulis if you have any questions related to the position.
Applicants will be considered on an ongoing basis.
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, plastampuller og hetteglass 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, Industri og produksjon, Medisinsk utstyr og rekvisita
- Stillingsfunksjon: Dokumentasjon, Ingeniør, Kvalitetssikring
- Arbeidsspråk: Norsk, Engelsk
Nøkkelord
engineer, quality, pharma, quality control, kvalitetsingeniør
meta.heading
- FINN-kode 371958946
- Sist endret